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Director GMP Compliance Biologics Job

Job Details

Director GMP Compliance Biologics-QUA004886

Description

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, Biologics and Microbiology GMP Compliance Remediation and Support will report to the Executive Director, Compliance Support and Remediation.

•Provides leadership and technical direction as a thought leader on application and implementation of regulatory GMP requirements and expectations for the assigned QMS sub-system:
•Fully understands regulatory requirement (FDA, DEA, EMA etc) and ensures such requirements are incorporated into Merck QMS requirements for the Sub-system.
•Ensures Quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve Quality policy. Influences and advocates Merck’s position on regulatory standards through a strong network of external connections and participation in related industry conferences and task groups. Anticipates external trends and prepares MMD for these changes by influencing strategy through recommendations to senior management on direction to take.
•Monitors Sub-system health and proactively identifies, investigates and resolves trends and patterns before they impact compliance and supply. Leads development and execution of significant innovative projects that drive operational improvements within the Sub-system.

•Leverages and improves capabilities, knowledge sharing and compliance within MMD by maintaining an integrated end to end network with strong connections to site SSO’s and SME’s.

Qualifications

Education Minimum Requirement:

•B.S., M.S. and/or Ph.D. in Microbiology science or scientific discipline required. (Industrial Microbiology degree desired)

Required Experience and Skills:

•A minimum of 10 to 15 years of Quality, Operational or technical experience within a Biotechnology Industry environment.
•Will have experience and exposure (not less than 5 years) managing (direct involvement with) regulatory inspections and communications in a Biotechnology company directly related to Quality, Compliance, Operations, Analytical Laboratories and/or Process technology.
•Will have experience as a Laboratory Manager within a Biotechnology industry.
•Knowledge of GMPs and regulatory requirements expectations.
•Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
•Able to travel 50% of the time.

Preferred Experience and Skills:

•Expert knowledge of international GMPs requirements of regulatory agencies
•Extensive experience in compliance remediation activities at plant sites (Not less than 5 years working in Compliance and/or Regulatory Department)
•Industrial Microbiology Educational Background
•Will have experience and/or exposure in Plant audits and Supplier Audits
•Experience in Regulatory Commitments implementation and effectiveness
•Accountable for actions, drives results, and learns from mistakes.
•Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions.
•Communicates influences and escalates issues and decisions, as appropriate.
•Goes to the shop floor to see the problems and work directly with people on the shop floor.
•Demonstrates tolerance for ambiguity.
•Experience in CAPAs effectiveness and Implementation
•Previous exposure to documents approval such as: Validation reports, Nonconformance investigations, Work orders and Change controls
•Is an active member of a related professional association (e.g. PDA, ISPE).

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​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Qual Assurance & Ops Generic

Job Title:Dir, Quality Assurance

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Whitehouse Station, NA-United States

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: No

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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