Director GMP Compliance

Merck USA - West Point, PA4.1

Full-time
Requisition ID: QUA008257

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, Quality Assurance works in the Compliance, Remediation, and Support team within MMD Global Quality Assurance. Position will provide compliance leadership and direction to Merck facilities and Contract Manufacturing Facilities (CMOs) that manufacture biologic and vaccine drug substance and finished product. Supports audits and Health Authority Inspections and ensures any resulting corrective and preventative actions (CAPA) are effectively implemented.

The individual will:
serve as a global subject matter expert for current good manufacturing practices (cGMP) related to vaccines and biologics manufacturing.
author and/or review global standards and procedures related to vaccines and biologics manufacturing, ensuring compliance with international regulatory expectations.
gather regulatory intelligence and partner with Merck and CMO Management to prepare vaccine and biologic manufacturing sites for Audits and Inspections. Assists sites during audits and Inspections to ensure successful outcomes.
partner with Merck and CMO Management to identify appropriate Corrective and Preventative Action Plan (CAPA) to address findings identified during audits and Inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Confirm effectiveness of CAPA following implementation to prevent recurrence.
monitor and analyze the outcomes of audits and Inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality/management Councils.
actively participate in industry organizations such as, PDA, PQRI, PhRMA, ISPE, etc.

Qualifications

Required Experience and Skills:
A minimum of 10 (preferred >15) years of Quality, Operational or technical experience within a Biotechnology or Vaccine manufacturing environment.
Expert knowledge of GMPs and regulatory requirements and expectations related to vaccine and biologics manufacturing.
Experience and exposure (not less than 5 years) in performing or managing health authority inspections and communications at vaccines or biologics manufacturing facilities.
Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
Strong technical background and knowledge of biologics and vaccines manufacturing operations
Strong demonstrated interpersonal, communication, collaboration and leadership skills
Able to travel up to 50% 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
> 5 years’ experience in auditing or compliance decision-making
> 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.