Quality Auditor - Scientific - III (Senior) Quality Auditor - Scientific - III (Senior)

Job Description

• 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 communicate project status to management.
• Independently audit applicable regulatory filings.
• Ensure compliance with regulatory 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.

• Foster Collaboration, Drive Results, Make Rapid Disciplined Decisions.
• Demonstrate 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.
• 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 request.
• Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues.

• 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.

• B.S., M.S. and/or PhD. degree in an appropriate Science, Engineering discipline.

• 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.

• Experience supporting Internal and/or external audits.