Director, Quality Control Analytical

Position Summary

• 100% on-site

Catalent, in Baltimore & Harmans, Maryland, provides industry‑leading GMP development and manufacturing services for cutting‑edge biopharmaceuticals such as recombinant viral vectors, next‑generation vaccines, hard‑to‑express recombinant proteins and oncolytic viruses.

The Director of QC Analytical is responsible for overseeing the Quality Control (QC) strategies and operations, including but not limited to the testing function in support of raw materials, in‑process and finished products of Phase I‑III and commercial programs. The Director, QC Analytical ensures compliance with GMP, company specifications, and relevant pharmacopeia compendia. The Director identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory.

The Director keeps laboratory management informed of all departmental activities and product‑related events.

The Director, Quality Control Analytical will report to the Head of Quality.

• Accountable for all activities within the QC Analytical department; leads the team on daily QC Analytical and QC Support Services strategies and ensures timely completion of job activity deadlines.
• Hires and trains QC department personnel; sets clear performance goals, tracks progress, provides constructive feedback, and addresses performance concerns promptly.
• Interacts with customers to assure expectations are established, agreed to, and achieved.
• Engages actively with Project Management and other departments to ensure GMP programs are properly supported to achieve expectations; maintains effective communication between all parties, including the customer.
• Identifies, maintains, and reports functional KPIs to site management.
• Assures execution of testing programs to assess the quality of raw materials, components, in‑process and finished goods, and effectiveness of production processes.
• Collaborates with leaders to generate new or revise Standard Operating Procedures for analytical test procedures.
• Performs other duties as assigned.

• Bachelor’s degree required and 10+ years of relevant experience with 8+ years of direct management experience.
• Experience in analytical testing required.
• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience preferred.
• Experience in a GMP environment, including ICH, FDA, USP, EP, and other applicable regulatory guidance (US and EU).
• Strong focus on responsiveness, ability to multi‑task, attention to detail, effective problem‑solving skills, and consistent follow‑up; ability to make timely and sound decisions (Quality and Business).
• Excellent communication and writing skills; patience, professionalism, and ability to interact effectively with staff and management across functional groups and levels.
• Creative individual with excellent problem‑solving and troubleshooting skills; able to work effectively under pressure to meet deadlines.
• Demonstrable leadership experience at Catalent (including participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

The anticipated salary range for this position in Maryland is $188,320 – $258,940 plus bonus. The final salary offered to a successful candidate may vary and will be dependent on several factors, including the type and length of experience within the job, industry, skillset, education, and business needs.

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Opportunity for career growth within an expanding team dedicated to preserving and bettering lives
• Dynamic, fast‑paced work environment
• Community engagement and green initiatives
• Generous 401(k) match and paid time off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help bring over 7,000 life‑saving and life‑enhancing products to patients worldwide. Catalent is…