Director, Quality Assurance and Compliance Job West Point United States,
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, Quality Assurance and Compliance reports to the Quality Operations Line of Business and supports all Quality Assurance and GMP compliance activities relating to the manufacture of vaccine products to ensure compliance with all applicable regulations and specifications.
1. Ensure Division Quality systems are effectively deployed to sites in the Operating Unit according to schedule. Evaluate site variances and ability of site to maintain level of compliance through the requested extension. Confirm closure according to plan.
2. Team with Site Compliance Directors in areas of compliance to proactively identify initiatives and quality system enhancements. Identify areas of continuous improvement for simple lean Quality system deployment (MPS) and ensures best practice sharing and drive improvement across sites. Champion various compliance initiatives according to Operating Unit and MMD priorities, as directed.
3. Maintain, communicate and evaluate the performance metrics of key Quality Systems and Quality Assurance programs across sites as per the drivers of KPIs as identified by Operating Unit/MMD, including but not limited to:
a. Change Control
b. Deviation Reduction
c. Inspection readiness and performance
d. Agency reporting of BPDRs and FARs, and market actions
e. CAPA and Commitment management
4. Support and contribute to internal and external compliance forums to identify and evaluate emerging trends for continuous improvement in Operating Unit related to Quality Systems requirements. These activities include:
a. RegIntel to leverage and drive improvements from significant investigations and/or current compliance trends with Merck
b. Attendance and participation in internal quality forums
c. Participation in industry working groups
d. Support enhancement of Operating Unit compliance performance through coordination with site compliance leaders
5. Act as the primary liaison for Quality Operations Unit leader assisting sites in complex compliance issues such as significant investigations and Fact Findings.
6. Support sites, as needed, during regulatory inspection and Divisional audits. This includes driving cross-site proactive approaches (mock inspection prep work and Quality Compliance & Excellence (QC&E). Assist in conduct of inspections, as needed, and assure responses are of high quality and represent both site perspective as well as Division perspective
7. Support Quality Operating Unit leader and sites to ensure high quality FARs, BPDRS, EU defect reports and on-time submission.
8. Serve as supporting member of Quality Standards Committee (QSC) by coordinating Operating Unit perspective on MMD policies and guidelines, and conversely, providing perspective of QSC to sites. Guide sites on implementation of Quality Alerts and Quality Bulletins
9. Support sites and Quality Operating Unit leader on fact finding and any recall activities by guiding sites on the preparation and follow-up of key activities, most notably follow-up actions from these meetings
Education Minimum Requirement:
- 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 ten (10) years of work experience in a pharmaceutical and/or vaccine manufacturing environment or strongly related, similarly regulated field.
- Strong understanding of cGMPs across multiple global regulatory agencies.
- Strong compliance mindset.
- Strong lean mindset with prior MPS/Kata capabilities is a plus.
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 email@example.com.
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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Dir, Quality
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Microbiology, Compliance, Manager, Engineer, Science, Legal, Management, Engineering
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