Director GMP Compliance

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.  The Director of GMP Compliance will report to the Executive Director of Compliance Support and Remediation and will work very closely with the Executive Director of Quality Management Systems. The responsibility of this position crosses all Human & Animal Health operating units and requires extensive collaboration. The individual will: serve as a subject matter expert for good manufacturing practices for drug products, active pharmaceutical ingredients, vaccines, and devices  ensure new and developing global standards and procedures impacting Merck manufacturing sites are fully compliant with international regulatory expectations trend and analyze inspectional observations received across the network for impact to various above-site teams and impact to the network as a whole trend and analyze inspectional observations and enforcement actions within industry for impact and learning opportunities within the network develop and oversee program to share significant site-level inspectional observations between sites and above-site teams to prevent recurrence support remediation activities and pre-approval inspection readiness activities ensure all audits and Health Authority inspections are assessed and categorized for analytics and trending purposes supportaudit program by identifying audit targets and help develop protocols for targeted assessments actively participate in industry organizations such as, PDA, PQRI, PhRMA, ISPE, etc. Qualifications Education Minimum Requirement: B.S., M.S., and/or Ph.D. in chemistry, chemical engineering, microbiology, biochemistry, biology, biological engineering, or similar scientific discipline required. Required Experience and Skills: At least 10 years of Quality, Operational or technical experience within a Biotechnology, Pharmaceutical, or Device Industry environment.  Expert knowledge of GMPs and regulatory requirements and expectations.  At least 5 years of experience in managing health authority inspections and communications in a pharmaceutical or biotechnology manufacturing site.  Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.  Strong technical background  Able to travel up to 20% of the time. Preferred Experience and Skills: Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other GMP/regulatory role Expert knowledge of international GMPs/requirements of multiple regulatory agencies  At least 5 years' experience in auditing or compliance decision-making At least 5 years' experience hosting inspections from various international regulatory authorities Accountable for actions, drives results, and learns from mistakes Demonstrates good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions Communicates, influences, and escalates issues and decisions, as appropriate Communicates effectively up and down, at all levels of the organization Goes to the shop floor to see the problems and works directly with people on the shop floor Demonstrates tolerance for ambiguity  Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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 OFCCP EEO Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations. Job: Quality Operations Other Locations: US; Whitehouse Station, NJ, US Employee Status: Regular Travel: Yes, 20 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck Requisition ID: QUA008210
Salary Range: NA
Minimum Qualification
11 - 15 years

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