Within this role you will be responsible for providing oversight for all aspects of cGMP compliance for Technical Operations.
As a Compliance Manager (Technical Operations), a typical day might include, but is not limited to, the following:
1. Evaluating Technical Operations, Engineering and/or Automation department systems and processes for adherence to cGMPs and industry best practices, and implement changes/improvements as needed.
2. Being responsible for on-boarding and setting priorities for direct reports within the department. Manages area through direct reports which may include Associate Managers and Managers with direct reports.
3. Leading audit readiness program and maintains regulatory requirements for Automation, Engineering and Technical Operations.
4. Interfacing regularly with Quality Assurance, Manufacturing and other departments or functional areas to facilitate decisions pertaining to quality system deliverables.
5. Taking responsibility for specifying and coordinating training, development, and compliance for Technical Operations, Automation, and/or Engineering Compliance personnel, including consultants.
6. Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations.
7. Acting as a liaison to Quality and Regulatory groups for Technical Operations, Automation, and/or Engineering departments to address potential compliance issues.
8. Providing primary support for all regulatory and partner audits and inspections.
9. Developing, tracking, trending, and maintaining Technical Operations, Automation, and/or Engineering department metrics for presentation to site leadership, including but not limited to: Audit readiness, PM's and/or PERs.
10. Leading development and review of departmental policies, Standard Operating Procedures, Work Instructions, Job Aids, System Design Specifications, and Equipment Specifications.
11. Providing support and assistance to department members for the initiation, review, submission, and administration of documents, including but not limited to; Impact Assessments, PMs and/or PERs.
12. Overseeing and administering Periodic Evaluation Reporting program for all automation systems.
13. Maintaining company reputation by enforcing compliance with FDA/EU regulations and any other applicable agency as required.
This role may be for you if:
1. You show solid leadership and project management skills with demonstrated track record of effective supervision of technical personnel.
2. You have a thorough ability to coach others on effective problem solving.
3. You possess excellent interpersonal, written, and oral communication skills.
4. You have a strong knowledge of cGMPs, GxP, CFR, Quality Systems, and/or other regulatory requirements.
5. You demonstrate the ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity.
6. You exhibit strong knowledge of word processing, spreadsheets, PowerPoint database management software, and PCs.
To be considered for this opportunity you should have a BS/BA in an engineering or scientific related field with 7+ years of related experience or an equivalent combination of education and experience. Preferred experience in working in a CGMP or regulated environment along with experience in a leadership role.
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