Company: SERES THERAPEUTICS, INC.
Job Type: Permanent, FullTime
Supplier Quality Assurance Manager
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.
Seres Therapeutics is a member of the Flagship Pioneering family of companies.
The Supplier Quality Assurance Manager will lead the development, management and execution of the SERES supplier quality program and processes. This role is responsible for the quality aspects of supplier quality management of suppliers that provide raw materials, drug product and services to SERES for GMP Operations. This position is responsible to ensure that suppliers are capable of meeting SERES's quality standards. The incumbent will also have additional responsibilities that include but are not limited to, providing quality support to SERES stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring supplier quality system documents.
What You'll Do
- Responsible for the development and execution of the supplier quality management program and processes for GMP suppliers.
- Manage the quality of drug product, raw material, and GMP service suppliers to ensure SERES and FDA requirements are met
- Develop and manage supplier audit program.
- Oversee and conduct supplier audits, ensuring any improvements or corrective actions are addressed to SERES's satisfaction.
- Qualify new suppliers per SERES policies and procedures.
- Negotiate, approve and manage quality agreements between SERES and suppliers
- Participate on a cross functional supplier management team with colleagues from Supply Chain, Purchasing, and Commercial Operations to assess, communicate, and manage supplier performance via scorecards and business meetings
- Develop and maintain supplier risk ranking including evaluating internal and supplier Preventive Controls
- Work collaboratively with suppliers and SERES Quality teams on Supplier Corrective Action Request (SCAR) process, ensuring effective corrective actions are being taken by suppliers.
- Oversee the Supplier Change Notification process, ensuring SERES is notified of supplier changes and SERES processes & procedures are thoroughly assessed and updated as required.
- Develop and maintain a current and accurate database of supplier quality management information such as Approved Vendor List (AVL), risk analysis results, supplier performance, etc.
- Helps drive a culture of continuous improvement.
- Assist with regulatory and 3rd party inspections.
- Performs other quality and compliance-related duties as assigned.
What You'll Bring
- Minimum 10 years of well-rounded Quality experience in the pharmaceutical or biotechnology industry.
- Minimum 3-5 years' experience of people management.
- Demonstrated ability building and leading quality teams with an emphasis on cross-collaboration with improved levels of quality compliance.
- Ability to evaluate complex compliance issues and concerns
- Experience in performing and supporting deviation investigations and developing appropriate CAPA activities.
- Bachelor of Science degree or equivalent in life sciences or engineering.
- Experience working in cross functional teams and managing the relationships and expectations of several key stakeholders.