GMP Quality Assurance Senior Manager

About the Role:

The GMP Quality Assurance Senior Manager will report into the Director Global GMP Quality Assurance. They will play an essential role in maintaining and supporting a reliable/compliant supply of SpringWorks products to both clinical sites and commercial distribution outlets.  Their primary responsibilities will entail being Quality point of contact for SpringWorks products. This involves working with both internal and external stakeholders/third party vendors to meet SpringWorks’ timelines for finished drug product release for clinical trial or commercial market supply. 

Responsibilities Include:

• Manage SpringWorks Quality Unit review and approval of CMO master documentation (e.g. specification documents, master batch records, label proofs, etc.) as well as executed batch records, QC release records, and stability test records for the manufacturing of drug substance and drug product.
• Work with Qualified Persons (QPs) to support QP certification for distribution of SpringWorks products to EU/UK clinical trial sites (Annex 16).
• Perform QA oversight of stability protocol data review and expiry dating of SpringWorks products
• Work with internal stakeholders and/or CMOs to perform deviation investigations in support of product quality (as applicable). Escalating to SpringWorks Senior Management, when necessary.
• Work with internal stakeholders and/or CMOs to initiate and implement change controls
• Participate in GMP compliance audits and complete risk assessments for supplier qualification (as required)
• Develop and implement procedures to support the evolution of the Quality Management System, as required.
• Serve as the delegate of the Director, GMP QA to represent GMP QA as directed.
• Drive PAI readiness activates to ensure CMOs for DS and DP are inspection ready
• Perform surveillance of the GMP space for new regulations or emerging regulatory trends and develop method/process to keep organization informed
• Perform other duties and responsibilities as assigned.

About You: Required Education, Skills, and Experience

• Education: Bachelor’s degree in a scientific or technical discipline.
• 5+ years’ experience working in Quality Assurance in a pharmaceutical/regulated environment/industry.
• Prior experience overseeing CMO quality for batch record review, deviation investigation resolution for drug substance and finished drug product. This could be a combination of working in Quality Operation/Manufacturing roles.
• Working level knowledge of key quality systems such as change controls, deviations, CAPAs, product complaints, and supplier qualification.
• Appreciation of quality risk management concepts.
• Proficiency in ICH Q10 requirements; working knowledge of 21CFR US FDA regulations, ICH guidance, and Eudralex GMPs.
• Experience with regulatory inspections is preferred.
• Possesses a broad understanding of requirements for manufacturing, packaging and laboratory operations.
• Ability to work both independently and collaboratively in a fast-paced matrixed environment
• Regularly interacts with senior management or executive levels on matters concerning several functional areas. Requires the ability to influence the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship or the goals of the organization .
• Ability to influence and drive decisions with key stakeholders.
• Establishes routine cadence of communication with key stakeholders.
• Excellent verbal and written communication, strong organizational and interpersonal skills.
• Experience with Veeva Vault and SAP preferred
• This position must be able to work East Coast hours.
• Ability to travel occasionally (>15%).

The expected salary range for this position is $122,100 - $160,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.