Quality Assurance Manager

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.

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.

At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group’s (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging.

Ensuring diversity, equity, and inclusion are integral to our organization’s DNA.

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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.

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