Job Id: P1323188BOSMM_1677855065 Apply Now

Key Responsibilities:

Under the direction of the department head, responsible for the overall success and effectiveness of GxP audit program.

· Support development, maintenance, and implementation an annual GxP audit plan in coordination with leadership with all GxP functional areas

· Select, train, and oversee external auditors; maintain external auditor training curriculum, records, CVs, etc.

· Work with the business leads to oversee the development of audit agendas designed to effectively assess auditee risk areas

· Lead internal GxP audits; provide training/direction to support auditors to facilitate internal audit capabilities

· Lead high‐priority external GxP audits and due diligence assessments as needed

· Schedule audits with external auditors per audit plan

· Schedule and facilitate pre‐/post‐audit meetings w/key stakeholders; manage completion of action items

· Assure audit project folders are prepared/maintained in Egnyte and manage access for designated users

· Evaluate and escalate potential critical observations and/or potential Unsatisfactory audit outcomes from contract auditors; prepare summary of available facts and initial analysis for senior management review

· Review audit reports to ensure they are clear and cover the most important information to support efficient development of meaningful CAPAs

· Prepare audit performance metrics to assure audit program is conducted per standards and SOPs

· Perform audit trending of audit findings to assist QA and organization in identifying potential risks and supporting continuous improvement

· Assure all audit plans, reports, CAPAs and certificates are appropriately archived

· Support supplier qualification activities including review of questionnaires and vendor approvals

· Evaluate Audit and Inspection Program processes for continuous improvement opportunities

· Support GxP Quality System projects, programs and functional area initiatives as required

· Support ongoing inspection readiness activities, as needed

· Up to 20% domestic and international travel required

Qualifications:

· 10+ years of experience in the pharmaceutical or biotechnology (or similar) industry

· 7+ years GxP QA Audit and/or Regulatory Inspection management experience

· 3+ years' experience as a GxP Lead Auditor

· Advanced knowledge and demonstrated experience in the applicable (e.g. FDA, EMA, WHO, ICH, etc.) GxP regulations, standards, guidelines, and expectations

· Advanced experience in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity

· Advanced project management experience; ability to manage cross‐functional teams

· Significant experience with QMS management and administration including eQMS systems

· Demonstrated ability to effectively organize and execute complex tasks

· Strong verbal and written communication (including presentation) and customer management skills

· Bachelor's degree in life sciences, or engineering

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