Associate Director, Pre-Commercial Quality Assurance

Catalent

1d • Onsite

About The Position

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. This Associate Director, Pre-Commercial Quality Assurance provides leadership and support in delivering technical excellence in compliance with cGMP, continuous improvement as well as meets internal business targets while exceeding client expectations. This functional role provides quality assurance leadership and oversight for all commercial manufacturing and laboratory operations onsite and at contract organizations (CMOs and CPOs)

Requirements

• PhD with at least 7 years of professional experience in QA/QC pharmaceutical manufacturing
• Master’s degree with at least 9 years of professional experience in QA/QC pharmaceutical manufacturing
• Bachelor’s degree with 10 years of professional experience in QA/QC pharmaceutical manufacturing
• At least 4 years of leadership/management experience required with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives
• Extensive technical skills in solid dose manufacturing and/or packaging; experience in contract manufacturing preferred
• Experience leading audit preparations
• Experience with electronic quality management systems such as deviation management, analytical investigations (OOS), CAPA and change control

Nice To Haves

• Experience in contract manufacturing preferred

Responsibilities

• Act as Pre-Commercial QA SME during FDA, non-domestic and client audits and lead preparation of responses to all audit observations, particularly those related to Pre-Commercial Quality Assurance findings
• Lead site cross-functional team effort to drive all pre-commercial CAPA commitments for audit responses and eQMS events to timely completion and effectiveness evaluation
• Lead the team-based approach for review and verification of drug product quality in manufacturing, packaging and testing records to ensure that only compliant product is released and non-conforming materials are investigated and dispositioned appropriately
• Lead in the development of a culture, and supporting systems, to drive open communication, participation and intra/inter-departmental idea-sharing to build an engaged team; advance and model company values and leadership commitments; ensure the highest levels of quality, compliance and integrity are adhered to in all interactions
• Direct operations within Pre-Commercial Quality Assurance while maintaining a continuous improvement philosophy focused on improved compliance, right-first-time and process efficiency while creating an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the commercial organization
• Establish and maintain active KPIs for the functional measures within Pre-Commercial Quality Assurance including periodic reporting for the KPIs; monitor and trend key Quality data for internal and external commercial supplies in support of the S&OP scorecard program

Benefits

• 152 hours of PTO + 8 paid holidays
• Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees