Senior Specialist, External Quality Assurance; EQA

Responsibilities

• Ensure that all Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.
• Evaluate and release products where applicable, ensuring compliance with approved processes and procedures, and review and approve changes to master batch records or laboratory methods/specifications.
• Compile, analyze, and report metrics, identify trends and root causes, and develop initiatives and process improvements.
• Oversee external‑entity (EE) activities for product release, confirming that the goods were produced or tested in conformance with Company policies and regulatory regulations.
• As the Qualified Person, certify batch compliance with Marketing Authorization and GMP, assessing deviations, out‑of‑spec results, and quality complaints.
• Verify supply‑chain and starting materials, ensuring that any third‑country batch is fully tested in the EU (unless an MRA applies) and that all regulatory commitments are met.
• Account for Quality Control functions, including oversight of product testing and related components as defined by the external‑entity oversight level and product segmentation.
• Operate safely and efficiently in compliance with the Safety and Health Policy.

Ability to travel up to 25%, occasionally on short notice.

• Minimum four‑year degree in Science, Engineering, or a related technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering).
• At least 5years of relevant experience in the pharmaceutical and/or biotechnology industry, with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP and regulatory requirements.
• Experience in a site Quality and Qualified Person role is preferred.
• Previous participation in regulatory inspections.
• Moderate contractual and financial awareness.
• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills; ability to build relationships across boundaries and to lead.
• Proficiency in English, both verbal and written.

• Previous experience as a Qualified Person, preferably in an EU QP licensee environment.
• Knowledge of domestic and foreign regulations and compendia governing plant operations.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.