Senior Specialist, Biologics Quality Operations External Manufacturing
Location:
West Point , Pennsylvania
Posted:
February 03, 2017
Reference:
QUA005507
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.

Responsible for ensuring that all Merck Therapeutic Protein and Biological products managed by BQOEM are manufactured, packaged, analyzed, released stored and distributed in accordance with Merck expectations and all applicable regulatory requirements. Ensures the Quality performance of external parties/partners through direct oversight, support and counselling to the partner's Quality unit. These activities include involvement in most aspects of external manufacturer operations related to the quality of products produced. The incumbent is responsible for the release of all manufactured products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies. The incumbent exercises a leadership role in monitoring and maintaining Biologics External Manufacturing (BEM) compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements.

Primary Activities

Possesses a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute Merck Therapeutic Protein and Biological products. Receives guidance on policy issues as well as general and specific direction with regard to operations from the BQOEM Associate Director or BQOEM Director.

For example:
  • Assures compliance with established policies/procedures of MMD and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
  • Operates in a safe and efficient manner and in compliance with the MMD QO Safety and Health Policy.
  • Supports the development and maintenance of a Quality Agreement with the external parties/partners. May provide input into the development of contractual agreements with the external manufacturers.
  • Reviews all audit outcomes pertaining to external manufacturers and ensures appropriate and timely corrective actions where warranted.
  • Acts in conjunction with the Director of BQOEM as the Merck Quality Operations point of contact to the external manufacturers. Responsible for coordination, oversight, and communication on matters related to the GMP status of the external manufacturer. Must be conversant with applicable regulations and compendia (domestic and foreign) governing the external party/partner's operations.
  • Closely collaborates with appropriate business/operations and technical areas to achieve MMD and Merck objectives.
  • Acts as the Merck Quality point of contact for the external party/partner and the liaison for contact and communications between the external party/partner and internal Merck personnel.
  • Exercises a program of calibrated Quality oversight based on the product type as well as the capabilities, quality and compliance performance of the external party/partner.
  • Tracks and monitors operational and quality performance of the external party/partner. Monitors efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forums.
  • Works with the external party/partner to ensure that effective and robust Quality systems and Quality management are in place. Provides on-site guidance in the preparation of metrics, procedures, and guidelines where warranted. Provides proactive support in training and coaching to implement quality improvements.
  • Provides guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
  • Responsible for evaluation and/or release of products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations.
  • In conjunction with other internal Merck departments ensures that Merck validation expectations are met, and external partners/parties are inspection ready for all new product introductions/transfers.
  • May act as a regulatory compliance liaison on Merck's behalf to interface with regulatory Agencies.
  • Assists in the coordination of significant investigations including Fact Findings. Assists in the coordination of any product recall involving the external manufacturer.
  • Conducts quality due diligence assessments for pre-approval considerations of new external partners. Supports the partner in remediation of due diligence and/or pre-contract audit gaps.


Qualifications:
Education:
  • BS degree in Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering (or equivalent).
Required Experience:
  • Minimum of 5 years' experience in biotechnology or pharmaceutical industry with a thorough knowledge of quality systems, regulatory requirements and GMP.
  • Must have strong knowledge of and broad experience in product Quality Assurance and Quality Control activities.
  • Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Communicates easily in English both verbally and in writing.
  • Must have very strong relationship building skills.
Preferred Experience:
  • Experience with biologic/vaccine Quality Assurance, SAP based MRP platform and Trackwise change control and customer complaint applications is preferred as is some level of contractual and financial awareness.

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 staffingaadar@merck.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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement​

Know someone who would be interested in this job? Share it with your network.