Associate Director, Animal Health, Global Quality Technical and Compliance Team

Merck

5d•$82•Hybrid

About The Position

We have an exciting opportunity for an Associate Director, Animal Health, Global Quality Technical and Compliance Team This role can be based at EU or US Animal Health sites The position is primarily responsible for executing and leading internal and external GMP audits following company`s auditing policy and guidance to ensure compliance with worldwide regulatory expectations. This includes ensuring that facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with company requirements and applicable global regulations. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.

Requirements

Bachelor Degree in Engineering, Biology, Chemistry or related field
Minimum of 5-7 years experience of manufacturing, technology, and/or quality experience within an FDA, an/or EU, API, Drug Product, Medical Device or equivalent environment.
Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination products, Biologics, Vaccines, API’s, Non-sterile Drug Products, or Sterile Drug Product manufacturing. Biologics auditing experience is required.
Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices.
Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
Ability to work independently with limited supervision in a virtual-management environment.
Excellent communication, negotiation, influencing, and strategic thinking skills.
Review and approve audit reports (as assigned).
Must be detail oriented and organized.
Must be a positive change agent and able to adapt in a dynamic environment.
Must have the ability to travel globally approximately 25% of the time.

Nice To Haves

Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives.
Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas.
Knowledge and expertise in application of Quality Risk Management pertaining to auditing.
Lean six-sigma belt / demonstrated process improvement experience.
External engagement in regulatory or industry forums.
Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.

Responsibilities

The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers. This requires approximately 25% worldwide travel.
Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.
Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.
Maintain an understanding our company policies, procedures, and guidelines.
Maintain awareness of evolving industry and regulatory trends/regulations.
Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits.
Coordinate with Site Quality leads on audit refusals and postponements.
Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations.
The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.
Maintain a broad based expertise of cGMP's, Company Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.
Maintain awareness of evolving industry and regulatory trends/regulations.
Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.
Provides support and administrative functions for the electronic Supplier Tracking and Repository System, and assists in data maintenance.