Associate Director, QC Compliance

General Description:

The Associate Director, QC Compliance will lead and manage all activities related to Quality Control lab compliance to ensure adherence to GMP guidelines in the manufacturing and testing of large and small molecule products. This role will focus on establishing QC compliance protocols, ensuring effective quality assurance processes, and maintaining regulatory compliance with FDA/EU regulations. The Associate Director will also support the development and implementation of compliance procedures and lead investigations related to compliance deviations. This role is located at the Hopewell, NJ site.

Essential Functions of the job:

• Develop, implement, and maintain Quality Control compliance programs in alignment with regulatory standards and internal policies.

• Lead and manage laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and Other Exceptions (OOE) results, ensuring thorough evaluation and adherence to cGMP regulations.

• Oversee the preparation and technical writing of compliance-related documents, including SOPs, compliance reports, deviation and CAPA records, and change control impact assessments.

• Lead the establishment of a compliance monitoring program, including participation in internal and external GMP audits to ensure laboratory adherence to industry standards.

• Collaborate daily with Quality Assurance to maintain and improve the health of the quality management system.

• Collaborate cross-functionally with other departments including Regulatory Affairs, Manufacturing, and Quality Assurance to facilitate successful regulatory submissions and compliance initiatives.

• Champion a sustainable culture of quality, compliance, accountability, and continuous improvement across the QC organization.

• Guide and mentor QC compliance and review staff to enhance their capabilities, fostering a high-performing culture and promoting professional development.

• Actively participate in risk assessments and assist in developing CAPA plans to tackle any compliance issues or potential risks efficiently.

• Ensure effective communication and training regarding compliance standards and regulatory expectations across the QC laboratory team.

Core Competencies, Knowledge and Skill Requirements

• Bachelor of Science degree and 8+ years of relevant working experience in an FDA-regulated biotechnology or pharmaceutical manufacturing environment required.

• Master’s degree and 6+ years of related scientific experience preferred

• 5+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

• Extensive knowledge of cGMP/EU GMP regulations and compliance, especially relating to large molecule manufacturing.

• Strong leadership and team management skills, with proven capabilities in mentoring and developing staff.

• Excellent analytical and problem-solving capabilities, with a track record of resolving complex compliance issues.

• Highly effective communicator, both written and verbal, capable of engaging with technical and non-technical stakeholders.

• Strong project and program management skills with experience directing multiple priorities within a fast-paced environment.

• Attention to detail and commitment to producing quality work, with the ability to work proactively and independently.

Supervisory Responsibilities:

• Manage and mentor a dedicated team of 1-2 QC compliance professionals, including data reviewers.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

• Experience with Veeva and ThermoScientific LIMS is a plus

Travel:

• Must be willing to travel approximately 20%

• Ability to work on a computer for extended periods of time

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.