Quality Auditor - Scientific - III (Senior)

About the position

The Lead Auditor position requires an individual to maintain an expert level of knowledge related to Good Manufacturing Practices (GMP) requirements and industry trends as described in applicable worldwide regulations. The successful candidate will advise supported areas on requirements for all assigned project responsibilities related to quality and communicate project status to management effectively. This role involves independently auditing applicable regulatory filings to ensure compliance with regulatory requirements and working collaboratively with various areas to resolve any audit findings. In addition to auditing, the Lead Auditor will identify training needs and oversee, develop, and/or conduct training or orientation sessions for internal staff and client groups, while also ensuring that they stay current with their own training requirements. The individual will be responsible for identifying the need for and/or developing Standard Operating Procedures (SOPs) to ensure that practices are accurately reflected. Representing GMP Quality (GMPQ) on inter-departmental and cross-functional teams is essential, ensuring the flow of information and providing quality guidance throughout the organization. The Lead Auditor will independently prioritize activities in support of multiple projects and support preparations for regulatory agency inspections. This role requires fostering collaboration, driving results, and making rapid disciplined decisions. The candidate must demonstrate excellent organizational skills, effectively manage multiple projects, and delegate audits to support team members or auditors as necessary. Maintaining positive working relationships within the Chemistry, Manufacturing, and Controls (CMC) auditing team and client areas is crucial, as is sharing and applying lessons learned. Clear communication skills are necessary to express information in a concise manner, and interpersonal skills are essential for effectively leading audits. The Lead Auditor will also attend project team meetings, act as a single point of contact, and keep close track of submission timelines while meeting deadlines and maintaining all audit goals. Identifying and managing issues on a continuous basis, such as unacceptable source documents or delays in comments resolution that impact submission timelines, is a key responsibility. The individual will provide guidance to project teams in specific situations regarding sources, audit maps, and workflows, and will update the auditing team with changes in submission timelines or other relevant changes. Prioritizing audit sections based on CMC requests and effectively listening to auditees to understand differing perspectives to resolve audit issues are also critical components of this role. Specific and/or additional duties may include providing tracking, trending, and metrics for GMPQ auditing activities, offering technical guidance to senior management in evaluating systems/tools, and assisting GMPQ staff and client areas with the technical aspects related to the use of electronic audit tools. Supporting process improvement initiatives for CMC clients and the auditing area is also expected.

Responsibilities
• Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations.
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• Advise supported areas on requirements for all assigned project responsibilities as related to quality and communicate project status to management.
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• Independently audit applicable regulatory filings. Ensure compliance with regulatory requirements. Work with areas to resolve any audit findings.
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• 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, and make rapid disciplined decisions.
,
• Demonstrate excellent organization skills and effectively manage multiple projects, delegating audits to support team/auditors as necessary.
,
• Maintain positive working relationships within CMC auditing team and client areas, sharing and applying lessons learned.
,
• Hold self and others accountable, demonstrating clear communication skills.
,
• Demonstrate interpersonal skills to effectively lead an audit.
,
• Attend project team meetings and act as a single point of contact.
,
• Keep close track of submission timelines and meet deadlines while maintaining all audit goals.
,
• Identify and manage issues on a continuous basis, such as unacceptable source documents or late submission of audit documents.
,
• Provide guidance to 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.
,
• 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.

Requirements
• B.S., M.S. and/or PhD. degree in an appropriate Science or Engineering discipline.
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• Minimum of 5-10 years' experience with B.S./M.S., or five (5) years with PhD in pharmaceutical/biotechnology, quality or compliance role.
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• Extensive working knowledge of cGMPs and technical aspects of support area are required.
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• Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary.
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• Previous experience in computer science, IT, quality assurance, auditing, or regulatory submission requirements.

Nice-to-haves
• Experience supporting internal and/or external audits.

Benefits

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