Director, GMP QA

1 month ago

South San Francisco, United States Meet Full time

Title: Director, GMP QA


Company Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to bringing transformative treatments to patients worldwide. We are partnered to recruit an experienced Director of GMP QA to join their team and contribute to their mission of improving patient outcomes.


Position Overview: As the Director of GMP QA, you will play a critical role in ensuring compliance with Good Manufacturing Practice (GMP) regulations and standards to maintain the quality and integrity of products throughout the manufacturing process. You will lead a team responsible for overseeing quality assurance activities related to GMP manufacturing operations, including manufacturing, testing, packaging, labeling, and distribution.


Responsibilities:

-Develop and implement quality assurance strategies, policies, and procedures to ensure compliance with GMP regulations and standards.

-Provide leadership and guidance to the GMP QA team, fostering a culture of quality and continuous improvement.

-Collaborate with cross-functional teams, including manufacturing, quality control, regulatory affairs, and supply chain, to ensure alignment and consistency in quality processes.

-Review and approve GMP documentation, including batch records, validation protocols, deviations, and change controls, to ensure compliance with regulatory requirements.

-Conduct internal audits and oversee external audits by regulatory agencies and third-party partners, ensuring timely resolution of findings and implementation of corrective actions.

-Lead investigations into quality events, deviations, and non-conformances, identifying root causes and implementing corrective and preventive actions (CAPAs) to prevent recurrence.

-Stay current with evolving regulatory requirements and industry best practices related to GMP manufacturing, providing guidance and training to internal stakeholders as needed.

-Serve as the primary point of contact for GMP QA-related inquiries from regulatory agencies, customers, and partners, ensuring timely and accurate responses.

-Drive a culture of quality and compliance throughout the organization, promoting awareness and understanding of GMP requirements and principles.


Qualifications:

-Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.

-Minimum of 6 years of experience in quality assurance within the pharmaceutical or biotech industry, with a focus on small molecule GMP manufacturing.

-Extensive knowledge of FDA and international GMP regulations and guidelines.

-Strong leadership and management skills, with experience leading and developing high-performing teams.

-Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional areas and influence stakeholders at all levels of the organization.

-Proven track record of managing GMP QA activities in a fast-paced, dynamic environment, with the ability to prioritize and manage multiple projects simultaneously.

-Experience with regulatory inspections and audits, including preparation, hosting, and response management.

-Detail-oriented mindset with a focus on continuous improvement and driving excellence in quality and compliance.

  • Director, GMP Quality Assurance

    4 weeks ago

    South San Francisco, United States Alumis Full time

    Job Description Job Description Salary: Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are...

  • Director, GMP Quality Assurance

    2 weeks ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are seeking a Director of GMP Quality...

  • Director, GMP Quality Assurance

    1 month ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are seeking a Director of GMP Quality...

  • Director, GMP Quality Assurance

    1 month ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are...

  • QA Director

    4 weeks ago

    San Francisco, United States Red Kite Recruiting Full time

    We're working with a better-for-you meat processor looking to identify a driven QA Director to join their SQF facility in Northern California. My client is primarily retail but is expanding into foodservice as they continue to grow. The QA Director acts as the liaison between production, quality and regulatory. This person supports the facility and QA...

  • QA Manager

    5 days ago

    San Francisco, United States Red Kite Recruiting Full time

    We're working with a better-for-you meat processor looking to identify a driven QA Director to join their SQF facility in Northern California. My client is primarily retail but is expanding into foodservice as they continue to grow. The QA Director acts as the liaison between production, quality and regulatory. This person supports the facility and QA...

  • Senior Manager, GMP Quality Assurance

    1 month ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.We are seeking a Senior Manager of GMP Quality...

  • Part-time Temp/consultant QA Gmp Auditor

    4 weeks ago

    San Diego, United States Poseida Therapeutics Inc Full time

    Description: **Please note that this is a part-time temporary/consultant position. Need is for 24 hours a week, 2 days a week expected to work onsite. **Position Summary** The GMP Auditor/Consultant is responsible for planning and conducting quality audits (Quality auditing oversight) related to GMP vendors and for qualifying vendors. This role will...

  • Director, Clinical QA

    4 weeks ago

    San Francisco, California, United States Proclinical Staffing Full time

    Proclinical are recruiting for a Director, Clinical QA (GCP) to join a biotech organisation. This role is on a permanent basis and is located in the Bay Area.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance. Responsibilities:Monitor the CQA Systems, which involves leading improvement...

  • QA Manager

    5 days ago

    South Plainfield, United States Kashiv BioSciences LLC Full time

    Job Type Full-timeDescriptionPosition Summary The Quality Assurance Manager is responsible for maintenance of Kashiv's quality management system. This role will oversee and direct the activities of the QA organization. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and QMS systems such as Deviations,...

  • Associate Director, Clinical Supply Chain

    2 weeks ago

    South San Francisco, United States DSJ Global Full time

    2-3 days onsite in SF REQUIRED About: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the...

  • Sr. QA Specialist

    4 weeks ago

    San Pablo, United States 153136 JOINN Biologics Full time

    Job DescriptionJob DescriptionDescription:JOINN Biologics is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to...

  • Associate Director, Clinical Supply Chain

    2 weeks ago

    South San Francisco, United States DSJ Global Full time

    2-3 days onsite in SF REQUIREDAbout: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development...

  • Associate Director, Clinical Supply Chain

    2 weeks ago

    South San Francisco, United States DSJ Global Full time

    2-3 days onsite in SF REQUIREDAbout: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development...

  • Director, Clinical Quality Assurance

    7 days ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.   Alumis is hiring a Clinical Quality Assurance...

  • Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Director, Clinical Quality Assurance

    1 week ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Gmp Coordinator I

    2 hours ago

    San Diego, United States Revvity Full time

    **Job Summary** While the role is a “Day Shift*”, it is anticipated that production runs may be required to start earlier in the day or end later in the day than a standard Day Shift. The coordinator is required to have a flexible schedule and be able to support earlier or later schedules and, as needed, be available for Saturday or Sunday shifts, with...

  • Quality Assurance Manager

    3 weeks ago

    South San Francisco, United States Shaw Bakers Full time

    About Shaw BakersAt Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggressive, fast-growing company with a full pipeline of exciting new projects, products,...

  • Quality Assurance Manager

    3 weeks ago

    South San Francisco, United States Shaw Bakers Full time

    About Shaw BakersAt Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggressive, fast-growing company with a full pipeline of exciting new projects, products,...