Position Summary:
Mauricio Ducassi is looking for a Director of Quality Assurance for an Aspetic-based CDMO client. The Director of Quality Assurance is a key member of the executive leadership team responsible for overseeing and ensuring the highest standards of quality across all manufacturing and operational functions. This role requires deep expertise in aseptic manufacturing and a demonstrated track record within the Contract Development and Manufacturing Organization (CDMO) space. The ideal candidate will lead quality assurance strategies that support sterile injectable product development, clinical supply, and commercial manufacturing services while ensuring full compliance with FDA, EMA, and global regulatory expectations.
Key Responsibilities:
- Serve as the primary authority on Quality Assurance across sterile, aseptic, and parenteral manufacturing processes.
- Direct and oversee all aspects of the Quality Management System (QMS), including document control, batch release, investigations, deviations, CAPA, change control, and product complaints.
- Ensure site-wide compliance with current Good Manufacturing Practices (cGMP), aseptic processing guidelines, and other applicable regulatory requirements.
- Lead, mentor, and develop a high-performing QA team, including QA Operations, QA Compliance, and QA Validation personnel.
- Collaborate cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, and Product Development teams to support internal and client-driven projects.
- Drive a culture of continuous improvement, right-first-time execution, and risk-based decision-making.
- Act as the quality lead during client audits, regulatory inspections (e.g., FDA, EMA), and third-party vendor assessments.
- Review and approve critical quality documents including batch records, validation protocols/reports, and specifications.
- Establish and monitor key quality performance indicators (KPIs) and report to senior leadership.
- Serve as the client-facing QA authority for project kickoff meetings, quality agreements, and ongoing technical discussions.
- Provide strategic input for new equipment qualification, facility expansions, and technology transfers.
Qualifications:
- Bachelor's degree in Chemistry, Pharmacy, Microbiology, Engineering, or related scientific discipline is required; advanced degree (MS or PhD) preferred.
- Minimum of 10 years of progressive Quality Assurance experience in the pharmaceutical industry, with at least 5 years in a senior leadership role.
- Proven experience working in a CDMO environment supporting sterile drug products (vials, syringes, lyophilized formulations, etc.).
- Extensive knowledge of aseptic processing, sterile fill/finish operations, and microbiological controls.
- Demonstrated success navigating regulatory inspections (e.g., FDA, EMA, MHRA) and client audits.
- Strong leadership, communication, and organizational skills with the ability to lead cross-functional teams.
- Deep understanding of cGMPs, ICH guidelines, and global regulatory frameworks.
- Experience implementing and scaling Quality Systems in a fast-paced, growth-oriented environment.
Location:
North Brunswick, NJ