Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Director, West Point Quality Systems, reports to the Director, West Point Quality Assurance, and has a dotted line reporting structure to the Executive Director, West Point Site Quality. This position supports all activities to realize key deliverables of the Quality System Improvement Program (QSIP), Quality Management System (QMS) installation and Quality Risk Management (QRM) deployment at the West Point Site. This includes management of a small team of cross functional individuals and numerous matrix reports to achieve the QSIP and QRM installation.
1.Ensure QSIP is effectively deployed and installed at the West Point Site according to schedule. Evaluate ability of site to maintain level of compliance. Evaluate requests for variances and/or requests for variance extensions. Confirm closure of remediation activities according to plan, inclusive of approved variances.
2.Represent West Point Site on the Divisional QSIP deployment team. Collaborate to ensure the right initiatives are deployed to enable the Site to realize the maximum benefit as quickly as possible in the overall implementation strategy.
3.Partner with the Site Quality Leaders and Site Operations Leaders in areas of compliance to proactively identify initiatives and Quality System enhancements. Serve in the role of coach and mentor to develop future compliance leaders in the LOB. Identify areas of continuous improvement for simple lean Quality system deployment (MPS/KATA) and ensure best practice sharing to drive improvement across the sites. Champion various compliance initiatives according to LOB/MMD priorities, as directed.
4. Support and contribute to internal and external compliance forums to identify and evaluate emerging trends for continuous improvements related to Quality Systems requirements. This includes serving as a conduit of information to the Divisional Quality System Improvement Leaders to support creation and installation ofproper Quality Manual guidance. QSC to sites.
5. Evaluate the performance and support QMS installation to enable monitoring and improvement of key Quality Systems and Quality Assurance programs across the Site and builds improved sub-sytem ownership capability, knowledge sharing and ability to improve Site compliance.
6. Monitors Sub-system health and proactively identifies, investigates and resolves trends and patterns before they impact compliance and supply. Leads development and execution of significant innovative projects that drive operational improvements within the Sub-system as per the drivers of KPIs as identified by LOB/MMD including but not limited to:
a.Deviation Reduction, Stability, and Change Control
b. Inspection readiness and performance, including preparation of inspection responses
c. Agency reporting of BPDRs, FARs, EU Product Defect Reports and market actions
d. CAPA and Commitment management related to regulatory inspections and notifications
7. Support sites, as needed, during regulatory inspection and Division Audits. This could include driving site proactive approaches (mock inspection prep work and Quality and Compliance Excellence activities). Assist in conduct of inspections, as needed, and assure regulatory responses are of high quality and represent both site perspective as well as Division perspective.
8. Responsible for hiring and ensuring Quality Assurance personnel are trained, and administers all personnel policies and development programs. Ensures personnel operate within established policies/procedures of Merck and in compliance with cGMPs and all applicable governing regulations.
9. Responsible for the deployment of Quality Risk Management to the West Point Site inclusive of:
a. Accountable for planning, leading and coordinating activities involved in the design/development, implementation and governance of a harmonized Quality Risk Management program including standards, business processes, tools and training for the Site
b. Responsible for partnering with customers across Site, key stakeholders (including IRM Lead) and management, to communicate/escalate and ensure timely and adequate identification and management of quality risks.
c. Provide QRM Program Design input to Divisional Quality and West Point Site Deployment
d. Quality Risk reporting and communication to the Site and potentially above site including oversight and maintainence of risk log/register
e. QRM Training Program implementation at the Site. Qualifications:
Bachelor's degree in an appropriate scientific or engineering field of study is required.
Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is a plus.
Required Experience and Skills:
- At least eight (8) years of work experience in a medical device, pharmaceutical, biologic and/or vaccine manufacturing environment or a strongly related, similarly regulated field.
- Concurrently, four (4) years of managerial experience, with responsibility for direct and indirect reports.
- Strong understanding of cGMPs, FDA and EMEA regulatory standards. Strong compliance mindset.
- Excellent writing skills.
- Strong lean mindset with MPS/Kata capabilities.
- Ability to be self-motivated and work independently, yet collaboratively in team settings and within matrix organizations to achieve objectives.
- Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
Preferred Experience and Skills:
- Previous work within Sterile/Vaccines manufacturing companies or regulatory authorities.
- Experience in compliance remediation activities at plant sites.
- Experience and/or exposure in Plant audits and Supplier Audits
- Experience in Regulatory Commitments implementation and effectiveness
- Minimum of two (2) different management pathway roles or experiences
- Accountable for actions, drives results, and learns from mistakes.
- Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions.
- Communicates influences and escalates issues and decisions, as appropriate.
- Goes to the shop floor to see the problems and work directly with people on the shop floor.
- Demonstrates tolerance for ambiguity.
- Experience in CAPAs effectiveness and Implementation
- Previous exposure to documents approval such as: Validation reports, Nonconformance investigations, Work orders and Change controls.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
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Visa sponsorship is not available for this position.
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