Senior Manager Quality Systems

2 weeks ago

San Diego, California, United States Erasca Full time
Job Title: Senior Manager/Assoc Director, Quality Systems

Erasca is a clinical-stage precision oncology company dedicated to discovering, developing, and commercializing innovative medicines for patients with cancer. Our mission is to make a meaningful impact on the lives of those affected by cancer.

Job Summary:

We are seeking a highly skilled Senior Manager or Associate Director of Quality Systems to lead the implementation and management of our Quality Management System. This individual will be responsible for supporting GXP Quality System activities, including training, document control, change control, quality events, corrective and preventive actions, audits, and vendor quality management.

Key Responsibilities:

  • Develop and implement GXP Quality Systems, including training programs, document control, change control, deviations, product complaints, temperature excursions, and corrective and preventive actions.
  • Administer electronic document management systems, including Veeva Quality Suite and DocuSign, and ensure compliance with 21 CFR Part 11 requirements.
  • Oversee the Vendor Quality Management program, including development and maintenance of the GXP audit schedule, qualification status of vendors, and CAPAs to resolve audit observations.
  • Develop and oversee the Internal Audit Program, coordinating audits, communicating results, and ensuring CAPAs are implemented to resolve audit observations.
  • Liaise with functions to ensure compliance with the Quality Management System, tracking and completing quality records, and identifying process improvements.
  • Assist in the development, review, and approval of SOPs for GXP operations and activities.
  • Collaborate with stakeholders to establish metrics and report the state of the Quality Management System.
  • Provide training to contractors and consultants supporting Quality Systems.

Requirements:

  • Undergraduate degree in life science or comparable experience in an FDA-regulated environment.
  • Minimum 8 years in GxP pharmaceutical environment in progressively responsible Quality roles, including at least 4 years of QA systems experience.
  • Previous experience with electronic document management systems, Veeva QualityDocs, and Veeva QMS modules.
  • Expert knowledge of GXP Quality Systems, including training, document control, change control, deviations, product complaints, temperature excursions, and corrective and preventive actions.
  • Previous auditing experience and working with FDA/global health authorities and participating in regulatory agency inspections.
  • Experience with Supplier/Vendor management and quality oversight of contracted vendors performing GXP activities.
  • Strong customer focus, ability to build relationships, and influence across functions and levels of the organization.
  • Strong organizational skills, ability to perform and prioritize multiple tasks, and excellent attention to detail.
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
  • Effective interpersonal and verbal and written communication skills, collaborative team player with a can-do attitude.

What We Offer:

Erasca offers a comprehensive and competitive benefits package, including paid time off, holiday and sick leave, medical, dental, and vision plans, short- and long-term disability, basic and voluntary life/AD&D coverage, flexible spending accounts, critical illness and accident coverage, pet insurance, employee assistance program, 401(k) plan with Erasca contribution, and employee stock purchase program.

Erasca is an Equal Opportunity Employer:

We take pride in maintaining a diverse and inclusive environment and do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of sex, race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status, or any other basis protected by federal, state, or local law or ordinance or regulation.

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