Associate Director, Quality Assurance, Operations

Purpose of the Position

The Associate Director, Quality Assurance, Operations will join a growing organization at a new sterile fill-finish manufacturing facility located just south of Richmond, Virginia. This role brings a high level of quality and compliance oversight to support the manufacture and supply of essential generic sterile and biosimilar injectable medications. Key responsibilities include establishing and maintaining quality systems and compliance frameworks across manufacturing operations to ensure that products meet cGMP and internal requirements from exhibit batches through validation and commercial supply.

This position is critical to ensuring that all operations align with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices). The role encompasses shop floor oversight, batch disposition, review and approval of deviation investigations and change controls, and the generation, review, and/or approval of policies, procedures, reports, batch records, and other necessary documentation. It also supports pre-approval and inspection readiness activities in pursuit of FDA approval of the facility and ongoing introduction of new medications.

Key Responsibilities

Essential functions include, but are not limited to:

• Provide leadership, direction, and support to Quality Assurance Operations and other departments to ensure team competency, safety, and performance.
• Lead the establishment and maintenance of quality systems for manufacturing and packaging operations to enable the reliable supply of quality sterile medications.
• Oversee all compliance aspects of sterile fill-finish manufacturing including batch records, change controls, deviation investigations, batch disposition, and shop-floor quality support.
• Ensure that handling, manufacturing, and distribution of pharmaceutical products comply with regulatory and internal cGMP requirements.
• Maintain current SOPs and training programs to support cGMP compliance through Quality Assurance shop-floor presence.
• Stay up to date with regulatory and industry trends to provide expert advice on quality-related matters.
• Lead operational inspection readiness and cross-functional preparation for health authority inspections.
• Support equipment qualification and process validation activities, including product and process transfers from development or other manufacturing sites.
• Ensure qualification of raw materials, excipients, APIs, and components, and approval of suppliers per cGMP requirements.
• Ensure timely release of components, materials, packaging, labeling, and drug products per approved specifications.
• Provide real-time oversight on the manufacturing floor, including batch record review and deviation response.
• Lead or support key quality systems and processes, including change control, CAPA, deviations, label control, laboratory control, product complaints, Annual Product Quality Reviews (APQR), and management escalation.
• Conduct and/or lead quality risk assessments.
• Take proactive, compliant, risk-based approaches to issue resolution.
• Lead deviation investigations when needed and implement corrective/preventive actions.
• Foster a quality-focused and safety-first culture across all operations.
• Maintain training systems and conduct or support training initiatives for site personnel.
• Participate in and/or lead regulatory inspections from U.S. and international health authorities.
• Travel up to 10% may be required.

The Candidate

• Bachelor’s degree in a scientific discipline and a minimum of 14 years of quality/cGMP experience in the pharmaceutical industry.
• Significant experience in sterile injectable manufacturing and packaging is required.
• Deep understanding of FDA and EMA requirements, including Annex 1 for sterile manufacturing.
• Proven experience supporting and leading regulatory inspections (FDA, EMA).
• Experience with Drug Enforcement Agency (DEA) compliance for controlled substances is a plus.
• Demonstrated project management and multitasking abilities in a fast-paced environment.
• Broad quality assurance experience across the development and commercialization lifecycle.
• Strong analytical and problem-solving skills with a pragmatic, compliant mindset.
• Strong interpersonal, written, and communication skills; proficiency with digital tools and systems.
• At least 7 years in a supervisory or managerial capacity.
• Adaptability, self-motivation, and the ability to thrive in a dynamic, start-up environment.
• A team player who is committed to high-quality results and collaborative problem-solving.