Quality Systems & Compliance Associate Director

Springworks Therapeutics • Torrance, CA

270d • $138,000 - $180,000 • Hybrid

About The Position

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. The Quality Systems and Compliance Associate Director is responsible for the establishment and continuous improvement of an effective, compliant and 'fit for purpose' quality management system. The major activities include but are not limited to the following: management and facilitation of the Approved Vendor List (AVL), scheduling of audits, deviation investigations, CAPAs, supplier audit closures, support of regulatory inspections, SOP writing and revision, Quality Council and change controls. In addition, this individual will support the end to end of supplier quality, that includes Supplier Periodic Reviews. This individual will also serve as the Veeva QMS business owner that will lead change management strategies that will improve Veeva functionality and increase efficiency for the end user and will support the SpringWorks Inspection Management process and provide regulatory intelligence regarding new regulations, regulatory authority guidance and enforcement.

Requirements

• 7 years of related experience with a Bachelor's degree in Life Sciences; or 5 years and a Master's degree; or a PhD with 3 years experience; or equivalent experience.
• 7 years of Quality-related experience in a pharmaceutical or biotech environment.
• Auditing experience.
• Supplier Quality experience.
• Working knowledge and understanding of ICH and global regulations to support regulatory intelligence.
• Ability to work effectively in a team environment, effective interpersonal and great organizational skills.
• Regulatory Inspections experience.
• Risk Management experience.
• Working knowledge of Veeva and Redica systems or equivalent.
• Ability to change the thinking of, or gain acceptance from, others in sensitive situations.
• Ability to lead and to interact and influence as an individual contributor.
• Work Style of agility and nimbleness.
• Ability to travel approximately 15%.

Nice To Haves

• 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 must be able to work East Coast hours.

Responsibilities

• Establish a risk-based supplier quality program that considers criticality, regulatory requirements, and business impact.
• Maintain Quality Management System (QMS), ensuring alignment with appropriate regulations and regulatory agency expectations.
• Ensure timeliness of Quality System closures (e.g. deviations, change controls and CAPAs).
• Establish, implement and maintain master audit schedule as part of the overall quality strategy.
• Interact with internal & external stakeholders including peers and Senior Management to align supplier quality goals.
• Generate Quality System metrics reports to report at Quality Council as per procedure.
• Act as the point person for Veeva QMS Business Owner to create operational efficiencies for end user experiences.
• Perform surveillance of the GxP space for new regulations or emerging regulatory trends and develop methods to keep the organization informed.
• Perform other duties and responsibilities as assigned.

Benefits

• The expected salary range for this position is $138,000 - $180,000.
• 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.
• Best-in-class benefits for our team of SpringWorkers.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree