Compliance Director, Biologics/Therapeutic Proteins/Sterile Quality Job - 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 Compliance, reports to the Executive Director Quality Compliance Biologics, Therapeutic Proteins and Steriles ( BTPS) Line of Business (LOB), and supports all Quality Assurance and GMP compliance activities relating to the manufacture of pharmaceutical, biologics and vaccine products medical devices and combination products, across the (LOB) to ensure compliance with all applicable regulations and specifications.
The responsibilities below are across the LOB but this specifically role will in the main support US activities:
1. Ensure Divisional Quality Systems are effectively deployed to sites in LOB according to schedule. Evaluate ability of site to maintain level of compliance, evaluates requests for variances and/or requests for variance extensions. Confirm closure of remediation activities according to plan.
2. Partner with the Site Quality Assurance (Compliance) leads in areas of compliance to proactively identify initiatives and Quality System enhancements. Identify areas of continuous improvement for simple lean Quality system deployment and ensure best practice sharing and drive improvement across sites.
3. Serve in the role of coach and mentor to develop future compliance leaders in the LOB.
4. Champion Global compliance initiatives e.g. Data Integrity, Quality Risk Management etc. according to LOB/MMD priorities, as directed.
5. Evaluate the performance of key Quality Systems and Quality Assurance programs across sites as per the drivers of KPIs as identified by LOB/MMD, including but not limited to:
a. Change Control
b. Deviation Reduction
c. Inspection readiness and performance, including preparation of inspection responses
d. Agency reporting of BPDRs, FARs, EU Product Defect Reports and market actions.
e. CAPA and Commitment management related to regulatory inspections and notifications
6. Support and contribute to internal and external compliance forums to identify and evaluate emerging trends for continuous improvement in LOB and across LOBs, related to Quality Systems requirements. These activities include:
a. Regulatory Surveillance to leverage and drive improvements from significant investigations and/or current compliance trends.
b. Attendance and participation in internal quality forums
c. Participation in industry working groups
d. Support enhancement of LOB compliance performance through coordination with site Quality Assurance / Compliance leads.
e. Interact with Compliance Directors in other LOBs to identify and address emerging and/or common issues across LOBs.
7. Act as the primary liaison for VP BTPS Quality, as assigned in assisting sites in complex compliance issues such as significant investigations.
8. Support sites, as needed, during regulatory inspection and Divisional audits. This includes driving cross-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.
9. Support VP BTPS Quality and sites to ensure high quality FARs, BPDRS, EU Product Defect Reports and on-time submission.
10. Serve as supporting member of QSC (Quality Standards Committee) by coordinating LOB perspective on MMD policies and guidelines, and providing perspective of QSC to sites. Guide sites on implementation of Quality Alerts and Quality Bulletins
11. Support sites and VP BTPS Quality 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.
Required Experience and Skills:
- At least 10 years of work experience in a medical device, pharmaceutical, biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field.
- Excellent working knowledge of cGMPs, FDA and EMEA regulatory standards.
- Excellent compliance mindset.
- Excellent writing skills.
- Ability to work collaboratively in team settings and within matrix organizations to achieve objectives.
- Strong lean mindset with MPS/Kata or other external lean capabilities.
Preferred Experience and Skills:
- Preferred fields of study include Biotechnology, Biology, Biochemistry, and Microbiology.
- An MBA or other business degree, in addition to the required science or engineering education, 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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Qual Assurance & Ops Generic
Job Title:Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-United States, NA-US-NJ-Whitehouse Station
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Microbiology, Medical Technologist, Compliance, Medical, Science, Healthcare, Legal