Associate Director, Digital & Data Quality Assurance
Job Description New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicatedto deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Digital & Data Quality Assurance Associate Director will be accountable for all quality aspects of assigned GMP computerized systems and supporting infrastructure utilized by our Manufacturing Division to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems used in support of GMP processes and which are required by our Manufacturing Division's Quality Manual or with potential for impact on product quality, patient safety or data integrity. The position will work closely with stakeholders and SME's from our Manufacturing Division's, quality operations and IT to provide evidence of quality oversight throughout the computer system lifecycle. The DDQ Associate Director must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients. Major Tasks including, but not limited to:
Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency Interfacing with our Manufacturing Division IT and other internal & external entities to align GMP shop-floor, laboratory, quality system and infrastructure technology capabilities/solutions with quality policies and objectives Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work Ensure IT systems that will be shared between new company and our company's implemented, maintained and monitored per all company requirements for compliance Ensuring a risk based procedure is implemented and executed to provide the independent quality approval of key qualification /validation documentation to ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle Providing quality & compliance consultancy and expertise regarding computerized systems and supporting infrastructure to supported areas, systems and projects Leading or playing a significant role on large multifunctional project teams Seeking to comprehend each team member's unique contribution and role Aligning team goals with regulatory expectations and our Manufacturing Division's quality objectives Developing a robust escalation process for identified risks to compliance or tasks on project critical paths are conveyed Driving results, remaining agile and being prepared Ensuring above site system owners have Operating Level Procedures/Plans (as required), approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Useand Administrative SOPs, disaster recovery plans, business continuity plans Leading pre-inspection IT readiness and supporting regulatory inspection and audit activities which includes the review of audit or inspection reports, answering to findings related to IT applications, automated manufacturing equipment, automated lab systems or infrastructure and taking appropriate actions to ensure GMP compliance Representing Digital and Data Quality Management in local and above site meetings regarding computerized systems selection, operation and/or compliance related issues Monitoring and conveying system health, compliance and other metrics updates to key stakeholders Promoting GMP awareness, innovation and a culture of continuous improvement regarding IT enabled GMP processes and validation activities Maintaining, updating, enhancing quality SDLC processes supporting our Manufacturing Division's computerized systems. This includes exercising the authority and influence to standardize processes globally Driving the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems Effectively and efficiently managing Digital and Data Quality resources. This includes training and coaching Digital and Data Quality employees Education Bachelor's degree preferably in Science, Information Technology, Engineering, Business or equivalent (Advanced Degree preferred) Required Direct experience with and comprehension of enterprise systems supporting pharmaceutical manufacturing operations, especially shared systems across multiple legal entities (companies) Minimum seven years in regulated pharmaceutical manufacturing with minimum three years delivering validated enterprise systems Strong comprehension of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulatory expectations for assigned areas Extensive knowledge of the principles, theories and concepts of computerized system validation/compliance Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment Operate as part of a self-directed team in carrying out day to day functions and assigning priorities Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching and team building Principled verbal and written communications Preferred Professional Certification like Six Sigma or a certification in project management (PMP) and/or Security Awareness Good understanding of GMP and Engineering Standards related to computerized systems development, implementation & Operations Business engagement skills, with ability to partner with both technical and non-technical roles Multi-lingual capabilities Leading conversation during regulatory inspections Analytical Problem solving skills applied to issue identification and resolution Comprehend business needs and map to IT technical solutions Timely decision making Ability to respond to changing priorities Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Pleaseclick here if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status:
Regular Relocation:
Domestic VISA Sponsorship:
No Travel Requirements:
25% Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$100K -- $150K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency Interfacing with our Manufacturing Division IT and other internal & external entities to align GMP shop-floor, laboratory, quality system and infrastructure technology capabilities/solutions with quality policies and objectives Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work Ensure IT systems that will be shared between new company and our company's implemented, maintained and monitored per all company requirements for compliance Ensuring a risk based procedure is implemented and executed to provide the independent quality approval of key qualification /validation documentation to ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle Providing quality & compliance consultancy and expertise regarding computerized systems and supporting infrastructure to supported areas, systems and projects Leading or playing a significant role on large multifunctional project teams Seeking to comprehend each team member's unique contribution and role Aligning team goals with regulatory expectations and our Manufacturing Division's quality objectives Developing a robust escalation process for identified risks to compliance or tasks on project critical paths are conveyed Driving results, remaining agile and being prepared Ensuring above site system owners have Operating Level Procedures/Plans (as required), approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Useand Administrative SOPs, disaster recovery plans, business continuity plans Leading pre-inspection IT readiness and supporting regulatory inspection and audit activities which includes the review of audit or inspection reports, answering to findings related to IT applications, automated manufacturing equipment, automated lab systems or infrastructure and taking appropriate actions to ensure GMP compliance Representing Digital and Data Quality Management in local and above site meetings regarding computerized systems selection, operation and/or compliance related issues Monitoring and conveying system health, compliance and other metrics updates to key stakeholders Promoting GMP awareness, innovation and a culture of continuous improvement regarding IT enabled GMP processes and validation activities Maintaining, updating, enhancing quality SDLC processes supporting our Manufacturing Division's computerized systems. This includes exercising the authority and influence to standardize processes globally Driving the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems Effectively and efficiently managing Digital and Data Quality resources. This includes training and coaching Digital and Data Quality employees Education Bachelor's degree preferably in Science, Information Technology, Engineering, Business or equivalent (Advanced Degree preferred) Required Direct experience with and comprehension of enterprise systems supporting pharmaceutical manufacturing operations, especially shared systems across multiple legal entities (companies) Minimum seven years in regulated pharmaceutical manufacturing with minimum three years delivering validated enterprise systems Strong comprehension of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulatory expectations for assigned areas Extensive knowledge of the principles, theories and concepts of computerized system validation/compliance Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment Operate as part of a self-directed team in carrying out day to day functions and assigning priorities Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching and team building Principled verbal and written communications Preferred Professional Certification like Six Sigma or a certification in project management (PMP) and/or Security Awareness Good understanding of GMP and Engineering Standards related to computerized systems development, implementation & Operations Business engagement skills, with ability to partner with both technical and non-technical roles Multi-lingual capabilities Leading conversation during regulatory inspections Analytical Problem solving skills applied to issue identification and resolution Comprehend business needs and map to IT technical solutions Timely decision making Ability to respond to changing priorities Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Pleaseclick here if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status:
Regular Relocation:
Domestic VISA Sponsorship:
No Travel Requirements:
25% Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$100K -- $150K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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