Associate Director, Site QC Head

About this opportunity :

Reporting to the Senior Director of Quality Control, this role oversees QC at the MAV Cincinnati site. Responsibilities include managing QC systems, ensuring compliance with procedures and data integrity, leading investigations of deviations/OOT/OOS, and ensuring the effectiveness of CAPAs. The Associate Director will champion lean operational practices and foster a culture of efficiency throughout the department.

Key Responsibilities:

• Responsible for managing all activities pertaining to the day-to-day operation of the Raw Material/In-Process/Release testing, Micro/EM testing, and Stability testing, which includes co-ordinate analytical activities between the various QC groups, AD and the Milford QC team.
• Ensure Right-First Time and On-time Delivery of testing results and documents.
• Establish and monitor metrics and KPIs to drive continuous performance and operational efficiencies within the QC group to assure budgetary expectations are met.
• By implementing Lean strategies and leveraging 5S principles, the role ensures that workflow is streamlined, waste is minimized, and every process is optimized for speed and accuracy.
• Collect feedback from staff, stakeholders, and audits to reinforce the culture of adaptability and responsiveness
• Provide technical review of procedures to ensure that test methods and specifications are scientifically sound and appropriate for use in QC.
• Accountable for ensuring that teams deliver against appropriate timelines for quality related issues, including complaints, Deviation, Change Control, and CAPA completions. Ensure repeating issues are caught and given priority for CAPA to prevent it from happening again.
• Ensure timely and effective interaction with customer representatives as appropriate.
• Prepare and present department metrics at site Quality Council and Quality Management Review meetings.
• Develop and drive annual department level goals that support corporate and site based annual goals
• Foster staff professional growth by coaching and cross-training. Ensure that the knowledge and training for QC staff aligns with evolving global regulations and guidance for pharmaceutical compounds (in general) and oligonucleotides (in particular), and develop appropriate solutions when gaps are identified.

Required Skills/Abilities:

• BS degree with 10+ years’ experience in managing a GMP lab or MS degree with 8+ years’ experience in chemistry, biology, or related field with 4+ years GMP-QC lab experience.
• Experience with HPLC, GC, CE, NMR, LCMS, USP testing and Wet Chemistry in a GMP laboratory setting.
• A thorough knowledge of ICH guidelines as pertaining to specification setting, method transfer and validation, stability study setting up and execution.
• Leadership skills and experience managing a high-performance team and leading cross- team activities.
• Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges.

The annualized salary range for this role is $135,000.00 - $165,100.00.