Quality Compliance Manager (on-site, Redmond, WA)
As part of the site quality Compliance team, the Sr. Compliance Manager focuses on ensuring site readiness and management of internal and third-party/client audits, as well as health authority inspections (FDA, EMA, etc.).
Responsibilities
- Manage and maintain the Compliance Risk Identification Process/ Risk Log.
- Lead / chair the Compliance Audit Response Team (CART), a cross-functional team comprised of representatives from several functional areas withing JEB Redmond and Seattle responsible for coordinating and preparing activities related to client audits and regulatory inspections.
- Own and maintain audit and inspection management logistics and SME preparation programs (i.e. Inspection Readiness Training and HA/Client Audit Interaction Training).
- Coordinate the end-to-end inspection readiness activities, including preparation and strategy sessions, instructor led training for subject matter experts, and managing audit and inspection related logistics.
- Ensure site personnel readiness by scheduling and conducting mock review sessions with subject matter experts.
- Coordinate cross functional activities focusing on development, review, approval and submission of responses for inspection and audit findings.
- Monitor and report status of remediation actions resulting from audit and inspection findings and drive efforts to ensure on-time completion.
- Review, analyze and distribute regulatory inspection / client audit data and trending issued by regulatory authorities to ensure proactive compliance across the organization.
- Develop and manage the inspection readiness annual plan, including identification of anticipated inspections.
- Coordinate document requests to support Health Authority Submission.
- Provide support for Compliance related / Health Authority report submissions.
- Support site notification to management program.
- Identify and execute continuous improvement initiatives within the Quality Compliance programs.
- Maintain Compliance procedures and documents in compliance with all applicable regulatory requirements to align with HA regulatory requirements / policies.
Qualifications
- Bachelor's Degree in Biochemistry, Biology, Microbiology, Chemistry, or a Scientific/Engineering degree.
- A minimum of 6+ years of relevant Quality, compliance, or regulatory experience in a GMP/FDA regulated environment.
- Auditing and regulatory inspection experience required.
- Extensive knowledge of global GMP and regulatory requirements as related to the pharmaceutical drug manufacturing process is required (Data Integrity, Part 11, etc.).
- Leadership experience required (direct leadership, project leadership, and/or indirect leadership).
- Ability to gown and enter the manufacturing suite as needed, and to stand or walk for up to two hours during facility tours.
The base pay range for this position at commencement of employment is expected to be $92,000 to $126,000; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
