Director, GMP Quality

Key Responsibilities

• Support Technical Operations Team and CDMOs with phase-appropriate cGMP oversight for both DP and DS manufacturing.
• Provide audit support or oversight of contract auditors for CDMO vendor audits as required.
• Foster collaboration and serve as GMP expert providing quality guidance, training, and direction to align with regulatory requirements and departmental goals.
• Support and participate in generating and ensuring adherence to Quality Management Systems including Document Control system and procedural lifecycle management.
• Provide quality oversight for manufacturing, packaging, labeling, testing, storage, and distribution activities.
• Establish and maintain quality policies, procedures, and standards.
• Review CDMO batch documentation and disposition to support research, development, and manufacturing release of DS and DP.
• Communicate progress and/or challenges in manufacturing to ensure product quality issues are escalated appropriately.
• Ensure effective management of deviations, CAPAs, change controls, complaints, investigations, risk assessments and quality metrics.
• Facilitate CAPA and effectiveness check requirements and improvements to ensure thorough investigations, deviations, product impact assessment, identification of the root cause and implementation of corrective action to mitigate recurrence.
• Drive continuous improvement initiatives to strengthen quality culture and compliance.
• Perform QC review of GMP data, documentation, or reports intended to support regulatory filings.

Qualifications

• Bachelor’s or advanced degree in scientific field.
• A minimum of 5 years of GMP quality oversight experience within a regulated life sciences environment, such as biotechnology or pharmaceutical company.
• Proven GMP leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done.
• Strong knowledge of cGMP regulations (21 CFR Parts 210, 211, 600s, EU GMP, ICH guidelines).
• Expertise in interpreting and complying with worldwide manufacturing regulations.
• Demonstrated ability to manage complex quality and compliance challenges.
• Must be solution-oriented and pragmatic with analytical thinking and problem-solving skills.
• Ability to analyze and summarize complex regulatory requirements and initiatives for stakeholders and to work through ambiguity.
• Exceptional time and project management.
• Exceptional communication skills with the ability to engage at all levels of the organization, fostering a collaborative and inclusive environment.
• Early-stage biotech startup experience is highly preferred.
• Willingness to spend 10-20 % of time travelling for audits and sponsor related meetings.

Salary Range

$190,000 to $230,000, commensurate with experience/expertise/level and could fall outside of the stated range