- Quality Compliance Manager (on-site, Redmond, WA)
- Just-Evotec Biologics Inc. in Redmond, WA, United States
- jobs
- 2 months ago
jobs description
Quality Compliance Manager (on-site, Redmond, WA)
As part of the site quality Compliance team, the 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
· 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 of 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 5+ years of relevant Quality, compliance, or regulatory experience in a GMP/FDA regulated environment.
· Working knowledge of GMP regulations and direct experience with regulatory compliance inspection, client audits and continuous improvement projects.
· Working knowledge of global GMP and regulatory requirements as related to the pharmaceutical drug manufacturing process is required (21CFR11, 210, 211, International Conference on Harmonization (ICH) Guidelines, Data Integrity, etc.).
· Able to work at a fast-paced environment.
· Experience with auditing of pharmaceutical manufacturing, testing, and storage operations.
· Leadership experience required (direct leadership, project leadership, and/or indirect leadership).
· Ability to gown and enter the manufacturing suite as needed.
· Ability to stand or walk for up to 2 hours during facility tours.
The base pay range for this position at commencement of employment is expected to be $91,560 to $125,350; 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.
Redmond WA United States