West Point, PA
6+ month contract
- Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations.
- Advise supported areas on requirements for all assigned project responsibilities as related to quality and Client Standards and communicate project status to management.
- Independently audit applicable regulatory filings. Ensure compliance with regulatory and Client requirements. Work with areas to resolve any audit findings
- Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements.
- Identify need for and/or develop SOPs to ensure practices are accurately reflected.
- Represent GMPQ on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.
- Independently prioritize activities in support of multiple projects.
- Support preparations for regulatory agency inspections.
- Consistently demonstrating Client Leadership Behaviors: Fosters Collaboration, Drive Results, Make Rapid Disciplined Decisions. Demonstrates excellent organization skills. Can effectively manage multiple projects, and delegate audits to support team/auditors. Request additional resources as necessary. Maintains positive working relationships within CMC auditing team and client areas. Share and apply lessons learned. Holds self and other accountable. Clear communication skills (express in a clear, concise manner).
- Demonstrate interpersonal skills to effectively lead an audit.
- Attend Project Team Meetings
- Act as a single point of contact
- Provide links of CMC Audit SOPs and SPR trainings (QM SOP 5.01, RCG-SOP 0233, SPR Training Slides, RAS SOP 840-1019, Risk Based Protocols)
- Keep close track of submission timelines and meets deadlines while still maintaining all audit goals.
- Identify and manage issues on a continuous basis (e.g. Unacceptable source documents, late submission of audit documents, delay in comments resolution that impacts submission time lines.)
- Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows.
- Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)
- Prioritize audit sections based on CMC’s request.
- Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues.
- Specific and/or additional duties may include, but are not restricted to:
- Provide tracking, trending and metrics for GMPQ auditing activities, Provide technical guidance to senior management in evaluating systems/tools. Assist GMPQ staff and client areas with the technical aspects related to the use of electronic audit tools.
- Support Process Improvement initiatives for CMC client and auditing area
Education:B.S., M.S. and/or PhD. degree in an appropriate Science, Engineering discipline.
Required Experience and Skills:
- Minimum of 5-10 years experience with B.S./M.S., or five (5) years with PhD. Experience should be in pharmaceutical/biotechnology, quality or compliance role. Extensive working knowledge of cGMPs and technical aspects of support area are required.
- Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities.
- Previous experience required to perform job responsibilities may include: computer science, IT, quality assurance, auditing, or regulatory submission requirements.