Associate Director Quality Assurance

Noramco,LLC•Hanover Township, NJ

14d•Onsite

About The Position

Serving as a QA head, the Associate Director Quality Assurance provides strategic leadership and direction to the site’s Quality Assurance function, ensuring the highest standards of cGMP compliance, product quality, and data integrity across solid orals, sterile/aseptic manufacturing, testing, and release operations. This role is accountable for establishing, maintaining, and continuously improving the Quality Management System (QMS) in alignment with US FDA (21 CFR Parts 210, 211, 820, and 11), EU GMP Part I and Annex 1, ICH Q-series (Q7–Q10), ISO 9001/13485, and client-specific quality agreements. The incumbent serves as the primary Quality Assurance authority for the site, providing oversight for manufacturing, validation, and quality assurance activities, ensuring inspection readiness at all times, and acting as the principal liaison during regulatory and client audits. This this is an on-site position based at our Whippany, NJ facility.

Requirements

Visionary leadership with a collaborative, results-driven approach.
Exceptional communication and presentation skills for regulatory, client, and executive interactions.
High integrity and decisiveness in managing compliance matters.
Strategic thinker with hands-on problem-solving ability.
Proven capability to manage multiple priorities in a dynamic, growth-oriented CDMO environment.
Ability to spend time in classified cleanroom areas in full gowning as needed.
On-site presence required to oversee operations, audits, and manufacturing quality activities.
Occasional travel to clients or supplier sites as required.
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, Microbiology, or related scientific discipline.
10+ years of experience in the pharmaceutical or biotechnology industry, with at least 7+ years in a senior Quality leadership role, preferably within a sterile/aseptic CDMO or manufacturing site.
Deep knowledge of US FDA 21 CFR Parts 210, 211, 820, and 11, EU GMP Part I and Annex 1, ICH Q-series, and ISO 9001/13485 requirements.
Proven track record of leading regulatory inspections (FDA, EMA, PMDA, MHRA, Health Canada, etc.) and successfully responding to observations or warning letters.
Demonstrated success in building compliant quality systems for tech transfers, process validations, new product introductions, and lifecycle management.
Strong understanding of sterility assurance, cleanroom qualification, environmental control, and data integrity programs.
Experience in client-facing CDMO operations, including quality agreements, audits, and product lifecycle support.

Nice To Haves

Advanced degree (Ph.D. or MBA) and/or ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred.

Responsibilities

Lead, develop, and manage all aspects of the site Quality Assurance (QA) functions, including compliance, validation, documentation, and batch disposition.
Establish, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with global GMP standards and client requirements.
Serve as the Quality Management Representative (QMR) to ensure QMS performance reporting to executive leadership and regulatory authorities.
Foster a culture of quality, data integrity, and continuous improvement throughout the organization.
Ensure full compliance with US FDA, EMA, PMDA, MHRA, Health Canada, and other applicable regulatory authority requirements.
Provide strategic oversight of all regulatory inspections and client audits, acting as site host, spokesperson, and decision-maker for QA.
Ensure timely and effective CAPA management, deviation investigation, change control, and risk assessment processes.
Maintain awareness of evolving GMP and Annex 1 requirements, ensuring site procedures are proactively updated to maintain compliance.
Provide QA oversight of aseptic filling, formulation, media fill programs, and environmental monitoring.
Ensure validated and qualified sterile manufacturing operations, including cleanroom classification, equipment qualification, and sterility assurance validation.
Review and approve key documentation such as batch records, validation protocols/reports, SOPs, Master Production Records, and analytical test methods.
Oversee quality risk management, contamination control strategy (CCS), and data integrity (ALCOA+) programs.
Oversee the supplier qualification and contract service provider management programs, ensuring vendors meet applicable GMP and quality standards.
Maintain active client communication regarding product quality, audit follow-ups, and/or regulatory commitments.
Review and approve quality agreements with clients, suppliers, and third parties.
Build, mentor, and lead a high-performing Quality Assurance team with a focus on accountability, empowerment, and regulatory compliance excellence.
Drive continuous improvement initiatives through metrics-driven performance reviews, trending, and management review programs.
Collaborate with cross-functional departments (Operations, Engineering, Business Development, Supply Chain, Product Development) to align business and quality goals.
Serve as the final quality assurance authority for product release decisions, ensuring all materials and finished products meet defined specifications and regulatory requirements.
Ensure robust control of GMP documentation, training, and change management systems.
Oversee quality management, validation lifecycle, and Annual Product Quality Reviews (APQRs).