Director, GMP Quality
As the Director of GMP Quality, you will be responsible for leveraging your extensive knowledge to ensure the development, manufacturing, and release of products to support the advancement of JLSa2’s pipeline. This role will lead compliance actions in partnership with internal stakeholders and external vendors to reduce and resolve issues across GMP projects. This role will allow you to have a major impact on our mission to support our patients.
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.
