Associate Director Quality
Job Description New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law,to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment. Our Quality organization ensures every single one of our products and their inputs are manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. We are seeking a growth and improvement minded Associate Quality Vaccine Manufacturing Director that can help drive our Strategic Operating Priorities. Invent Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs Execute Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business) Adapt Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape Diverse Talent We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world Values and Standards Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us The Associate Quality Vaccine Manufacturing Director is responsible for providing Quality direction and oversight to the West Point (WP) Site in the management of those areas assigned, such as Training, Documentation (including Standard Operating Procedures and Master Batch Records), Annual Product Review, Change Control, Inspection Management, Quality Management Systems, and Risk Management in order to maintain compliance with Regulatory requirements. The individual is an Advocate and Principal for the development, execution and deployment of WP Site and our company's priorities and drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for Quality oversight of vaccine formulation and filling operations as well as the associated Quality Systems and ensures compliance to Divisional, Company, and Site standards and procedures. This role partners with the Operations and Technical Operations Leaders to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements. The qualified candidate must demonstrate strong analytical and scientific acumen in order to assist with troubleshooting of processes and systems and will actively participate in external regulatory inspections. Additional Key Responsibilities Directly guides activities in the execution of quality system functions relating to GMP compliance; additionally, advocates multi-department teams regarding various compliance initiatives and assessments Creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business Establishing a Right First Time culture by reducing waste and constantly driving continuous improvement Author, review and/or approve compliance documents, as per procedures or need Coordinates and directs a team of multi-disciplined professionals in areas of process and systems as they relate to support and enhancements of quality systems Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Responsible for hiring and ensuring personnel are trained Ensure that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental) Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums Acquire and maintain technical process knowledge relevant to operations and testing. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations Proactively partner to implement continuous improvement actions to reduce deviations, reduce lead-time, and eliminate waste, while maintaining compliance Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents Achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and compliance risk Education Bachelor degree or higher in Science, Engineering or another technical fieldor equivalent experience in the pharmaceutical industry Required Work independently and as a Team member with Integrity Precision Accomplishment Motivational Spirit Respect Five years in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance or Supply Chain Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset Proven analytical aptitude, critical thinking skills, and ability to apply key concepts Working Across Boundaries Principled interpersonal, communication, collaboration and negotiation to work outside boundaries as a norm Preferred Business Outcomes/Drive Results - Ability to use deep knowledge and expertise in production operations to drive results and business outcomes Demonstrated experience of interacting with site, divisional or regulatory audits Create an engaged workforce using Inclusion as the How Knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion. MPS experience - LSS Green Belt certification or equivalent experience Proven ability to manage multiple projects simultaneously Applies knowledge of internal/external business challenges to improve products, processes or services Solves complex problems; takes a new perspective using existing solutions Works independently, receives minimal guidance Demonstrated self-starter with capability to develop innovative solutions to challenges Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing 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, digitalmastery, 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. 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. 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:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Not Specified Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Not Specified Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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