Associate Director External Site Quality Lead 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 position corresponds to a team leader responsible for implementing the Merck Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to Merck.
The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and drug delivery systems; executed under the direction or on behalf of the External Quality Assurance Director, and with particular focus on the deviation management quality system, including coordination of significant investigations and regulatory agency notifications.
These activities include assuring that products are manufactured from approved processes in conformance to all applicable regulatory requirements and Company policies. The incumbent will exercise a leadership role in monitoring and maintaining contracted third party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.
The incumbent may also ensure the quality performance of the Contract Manufacturer through direct oversight, support and technical advice, counseling to the third party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third party selection, GMP Due Diligence, and establishing of Quality Agreements.
The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the Contract Manufacturer; and maintains compliance with the Quality Agreements between the parties.
The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives, and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.
Education Minimum Requirement:
- BS degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent).
Required Experience and Skills:
- A minimum of eight (8) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination.
- Experience in Quality Agreement development and contract negotiation.
- Familiarity with Field Alert Reporting is also required.
- Must have strong knowledge of and broad experience in product Quality Assurance and Quality Control activities.
- Prior experience managing 3rd Party relationships.
- Demonstrated experience in quality risk management in the Pharmaceutical industry.
Preferred Experience and Skills:
- Strong demonstrated communication skills.
- Demonstrated personal networking and relationship building skills.
- Conversant on domestic and foreign regulations and compendia governing manufacturing operations.
- Contractual and financial awareness is preferred.
- Experience in Lean project implementation also preferred.
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.
Search Firm Representatives Please Read Carefully:
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.
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Job: Qual Assurce - 3rd Party Manuf
Job Title:Assoc. Dir, External Quality
Primary Location: NA-US-NJ-Whitehouse Station West
Other Locations: NA-US-PA-West Point, NA-United States, NA-US-NJ-Kenilworth, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: New Jersey
Job Segment: Microbiology, Law, Pharmaceutical, Manager, Pharmacy, Science, Legal, Management, Healthcare