Associate Director, Quality Assurance at Merck & Co, Inc in West Point, PA
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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Associate Director within the Quality Assurance Center of Excellence is accountable for providing Quality direction and oversight to West Point Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Deviation Management and Risk Management, in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of the West Point Site and our Manufacturing Division priorities. The Associate Director drives quality improvement activities and ensures alignment across Laboratory Operations in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems in Laboratory Operations in accordance with cGMPs, GLPs, international regulations and our Company guidelines, policies and procedures. The Associate Director will guide a team of individuals and support the development of personnel through effective coaching and feedback and by modeling inclusive behaviors. The Associate Director will lead key compliance projects for Laboratory Operations aimed at elevating the compliance posture. As a Project Manager, the individual is expected to fully manage all aspects of assigned projects, such as quality decision making, stakeholder management, issue identification and resolution, and driving all aspects of the project in alignment with established timelines. Additional Responsibilities Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations with the Laboratory Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices Serves as an Ad Hoc member of the West Point Site Quality Council Responsible for the Quality oversight and classification/approval of investigative events in Laboratory Operations Provides guidance to Senior Quality Specialists conducting reviews/approvals of investigative events Establishes the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product's quality Provide input on recommended CAPAs, as appropriate Completes review and approval for CAPAs, QCTS commitments, change requests, and investigative protocols and final reports Initiates and completes review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility Provides Quality consult to Senior Quality Specialists performing monthly internal audits of laboratory areas Reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc. Provides coaching and guidance to new personnel and to Quality Specialist and Sr. Quality Specialist colleagues Provides support to Regulatory Agency Inspections Proactively partners with Laboratory Operations and Laboratory Technology personnel to ensure that all process improvements and capital projects are timely, robust and in alignment with corporate goals Education Bachelor's degree in Life Sciences or related scientific field, with five years minimum in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality, OR Master's degree in Life Sciences or related scientific field, with three years minimum in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality Required Prior people management experience Quality Systems knowledge Project Management, Change Execution Management and Team Leadership experience in a Quality or related function Interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment Self starter with capability to develop innovative solutions to opportunities Facilitate management skills and able to lead cross-functional project teams to deliver results Proven analytical aptitude, critical thinking skills, and ability to apply key concepts Speaks with courage and candor Principled written and verbal communication skills In-depth working knowledge and application of GMPs/GLPs Proven ability to manage multiple projects simultaneously Preferred Risk Management tools and methodologies such as:
FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc. Fast learner and can be a change agent Technical understanding of Biologics, vaccines and small molecules business Understanding of our Company Quality System Direct floor manufacturing shop experience 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Other SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc. Fast learner and can be a change agent Technical understanding of Biologics, vaccines and small molecules business Understanding of our Company Quality System Direct floor manufacturing shop experience 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Other SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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