Associate Director, Quality Assurance
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.
This position is critical in Merck’s effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products with an objective to enable consistently compliant product quality, continuous improvement and effective life cycle management.
Act as a cross-functional leader to simplify, standardize & sustain our Compliance Remediation and Support (CRS) department, focusing on Contract/External Laboratories. Lead development and execution of significant innovation projects driving operational improvements related to Compliance, Remediation and Support. Support Health Authority inspections at contract/external laboratory sites. Partner with contract/external laboratory sites to identify and implement CAPA following audits and inspections, and provide CAPA management.
Primary activities include, but are not limited to:
- Develop strategy and lead implementation of the CAPA management process across the contract/external laboratory network; define the strategy for global requirements to drive harmonization of processes and systems related to contract/external laboratory management.
- Lead the implementation of QMS requirements related to CAPA Management and Compliance Remediation Support at contract/external laboratories.
- Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS processes and alignment related to GMP and Data Integrity requirements for contract/external laboratories.
- Provide leadership and technical direction on regulatory GMP requirements to contract/external laboratories.
- Initiate, where appropriate, and lead communities of practice to drive best practice sharing and continuous improvements across the MMD network
- Develop and proactively identify, investigate and resolve trends and patterns before they impact compliance and supply; define and drive implementation of performance metrics, as appropriate, to measure performance across the contract/external laboratory network
- Influence and advocate Merck’s position on CRS processes related to HA expectations through a strong network of external connections and effective external engagement.
- Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements.
- Lead, Act, and Support activities to ensure robust processes are in place and in use to maintain the Merck CRS and associated documents.
- Lead development and execution of significant innovation projects driving operational improvements; this will require cross-functional support within the Global CRS team and Global QA and External Affairs.
- B.S in Chemistry or Microbiology
- Thorough understanding of regulatory requirements related to testing of API, drugs, devices, biologics.
- Minimum of 10 years’ experience in an FDA and/or EU regulated pharmaceutical environment; preferably at a manufacturing site leading Quality and/or Quality Control and/or in a Global Quality function.
- Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS in an API, drug, device and biologics laboratory environment.
- Strong project management skills.
- Capable of working and communicating effectively with all levels of the organization globally
- Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management
- Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance
- Proven ability to effectively initiate and drive change
- Self-motivated with a high degree of ownership and accountability for results
- Demonstrated experience as a lead during Board of Health related inspections
- MSc or Advanced degree in Chemistry or Microbiology
- Experience in vaccines, biologics, devices and API regulations preferred
- Expertise working with Contract/External Laboratories, Manufacturers or Suppliers to drive change and improve compliance.
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.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck