Manager, GxP Audits

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Manager, GxP Audits

Waltham, Massachusetts


Full Time


$ 90 - $ 1,000 per hour

Waltham, Massachusetts

Full Time

$ 90 - $ 1,000 per hour

March 03, 2023


Job ID: P1323188BOSMM_1677855065

March 03, 2023

Job ID: P1323188BOSMM_1677855065

Job Summary

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


· 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


Apply Now

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™