Clinical Quality Assurance Associate Director

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.

Your Role:

The Clinical Quality Assurance Associate Director is responsible for building and maintaining the quality system with applicable GCP requirements. In addition, this role is responsible for contributing to the maturing of our Quality process and systems as well as providing quality oversight for our clinical trials. The Clinical Quality Associate Director reports to the Director of R&D Quality and works closely with Clinical Operations, our Contract Research Organizations, Medical Affairs and Regulatory, as needed. As the Associate Director, GCP is primarily responsible for developing, improving, and maintaining Phase Appropriate Quality processes and procedures supporting Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Good Pharmacovigilance Processes (GVP). This role will be instrumental in preparing for and guiding the Company through our pivotal trials and new drug applications.

Location Classification - Hybrid:

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid

Essential Duties and Responsibilities:

• Act as a senior member of the GCP QA team who will serve as the primary contact in QA for the oversight of Clinical Studies to ensure compliance with all Good Clinical Practice's to ensure compliance with all Regulatory requirements in the country the study is conducted.
• Design, establish and maintain phase appropriate Quality Systems to support clinical studies.
• Develop and implement GXP-compliant policies and procedures that are consistent, robust, and integrated into the company's Quality Management System.
• Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation.
• Develop and execute the global GCP vendor and clinical site audit plan strategies. Oversee and ensure that audits are conducted to high standards and are appropriately followed up with CAPA and effectiveness checks where required.
• Provide quality input to the development of regulatory strategies.
• Collaborate with cross-functional management, including the Head of Clinical, Medical Affairs, Regulatory Affairs, and Information Technology to drive clinical process improvements and alignments.
• Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies.
• Collaborate with CROs and Clinical business partners to ensure Quality Issues are appropriately addressed and documented.
• Plan, oversee/perform and follow-up audits of CROs, external laboratories, clinical trial sites.
• Perform other duties and responsibilities as assigned.

Role Requirements:

• Education: Bachelor's Degree in Life Sciences or technical discipline; Advanced Degree preferred
• 8+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GCP Compliance
• 4+ experience in Quality Assurance role
• Thorough understanding of clinical drug development, GCP, and familiarity with regulatory (FDA, Health Canada, and other global regulations) requirements for the conduct of clinical trials, including investigator-initiated studies
• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• Excellent analytical and problem-solving skills, with the proven ability to think strategically
• The ability to represent QA cross-functionally and globally; to apply understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
• Ability to interact with and influence Sr Leaders and internal stakeholder on important compliance topics and/or issues and drive to resolution
• Inclusive, people first team player with demonstrated examples of successful collaboration and engagement in a fast-moving environment
• Ability to assist in mentoring, coaching and development of peers and team members
• 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.

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

Compensation and Benefits:The expected salary range for this position is $152,234.00 - $200,000.00. 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 offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.

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.

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