Quality Assurance Manager - SpringWorks Therapeutics
Durham, NC
About the Job
About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.
SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
About the Role:
We are seeking a highly motivated individual to join as a GMP Quality Assurance (QA) Manager. This individual will report into the Senior Director Global GMP Quality and play an essential role in maintaining and supporting a reliable and compliant supply of SpringWorks products to clinical, compassionate use and commercial distribution channels.
Location Classification – Hybrid:
This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs.
Key Responsibilities:
- Primary responsibilities entail working with internal (CMC/product development) and external stakeholders (CMOs) to meet SpringWorks' timelines for drug substance and finished drug product release.
- 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 distribution channels
- Perform QA oversight of stability protocol data review and expiry dating of SpringWorks products.
- Work with internal stakeholders and/or CMOs to perform deviation/complaint investigations in support of product quality (as applicable).
- 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 maintain CMO performance metrics to demonstrate Sponsor oversight.
- Contribute to Annual Product Reviews for commercial products.
- Perform other duties and responsibilities as assigned
Qualifications:
- Education: Bachelors Degree in 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.
- Small molecule experience preferred.
- Working knowledge of key quality systems such as change controls, deviations, CAPAs, product complaints, and supplier qualification. .
- Knowledge of US FDA 21CFR 210/211 regulations, ICH guidance, and Eudralex GMPs and related practical application.
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
- This position will be required to be in office a minimum of two (2) days a week. #LI-Hybrid
Compensation:
The expected salary range for this position is $78,000.00 - $103,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.
SpringWorks Leadership Principles:
- Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
- Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
DE&I:
We believe in fostering a culture of belonging. Explore how we are committed to DE&I
EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
For more information see our Privacy Policy - Springworks (springworkstx.com)
