Associate Director, Quality Assurance CoE
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director within the Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned, such as general Focused Factory Support, Internal Auditing, Training, Annual Product Review, Change Control, Inspection Management, Documentation, Manufacturing Batch Records, MES, Quality Planning, and Risk Management in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of WP Site and MMD priorities.
The Associate Director drives quality improvement activities and ensures alignment across the site in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems at the West Point site in accordance with cGMPs and international regulations, Merck guidelines, procedures, and policies. Ad hoc member of the WP Site Quality Council.
The Associate Director will lead key compliance projects at the site aimed at elevating our compliance posture. Project Managers are expected to fully manage all aspects of assigned projects, including but not limited to: quality decision making, stakeholder management, issues identification and resolution, and drive all aspects of project in alignment with established timelines.
This role will be responsible for the deployment of Quality Risk Management to the West Point Site. The following are key roles within this particular position:
- Responsible for direct Quality Risk Management (QRM) Site deployment
- 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
- Responsible for partnering with customers across Site, key stakeholders and management, to communicate/escalate and ensure timely and adequate management of quality risks.
- Responsible for Site implementation of business processes for integration of Quality Risk Management into relevant elements of the Pharmaceutical Quality System (PQS)
- Able to travel as needed to support understanding of Divisional deployment requirements
- QRM Program Design input to Divisional Quality and West Point Site Deployment
- Implement QRM program for the West Point Site
- Develop and implement site QRM business processes in alignment with the QRM CoE program, including integration into QMS
- Quality Risk Reporting and Communication to the Site and potentially above site
- Manage site quality risk log/register & report site QRM metrics and status to the site, and appropriate global groups
- Ensure Site Risk register is maintained
- Develop and implement risk escalation model at the Site in alignment with the QRM CoE program
- QRM Expertise & Facilitation
- Provide leadership, QRM expertise and facilitation QRM activities at the Site
- Accountable for execution/facilitation review/approval of site level QRM activities;
- Ensures schedule based risk reviews occur
- QRM Training Program implementation at the Site
- Ensures that all those involved in QRM activities are trained per the QRM CoE training plan
- Use of and support of the QRM IT Tool Implementation at the Site
- B.S. degree in Life Sciences or related scientific field, with a minimum of 5 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility
- M.S. degree in Life Sciences or related scientific field, with a minimum of 3 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality
- Quality Systems knowledge
- Exposed to application of 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 Merck’s Quality System
- On the floor manufacturing shop experience
- Project Management, Change Execution Management and Team Leadership experience in a Quality or related function.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
- Demonstrated self starter with capability to develop innovative solutions to challenges.
- Demonstrated facilitative leadership 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.
- Strong written and verbal communication skills.
- In-depth working knowledge and application of GMPs/GLPs.
- Proven ability to manage multiple projects simultaneously.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck