Dir, Enterprise Quality Auditing

Job Description Summary

The Director, Enterprise Quality Auditing is responsible for providing oversight and direction to the Enterprise Quality Auditing (EQA) function. Responsibilities include but are not limited to:
- Overseeing and directing the India based auditing team who are responsible for the global external Quality auditing program of in-line and prospective Contract Manufacturing Organizations, Active Pharmaceutical Ingredient suppliers API and critical starting material suppliers based in these regions (India and JAPAC Region) for all Endo Subsidiaries.
- Overseeing and directing the collection, collation, analysis and publication of audit reports, observations, responses and Corrective and Preventative Actions from the External Manufacturing Inspection programs.
- Maintaining current and implementing new Quality Management Systems to support the Enterprise Auditing Function. Review and approval of EQA SOP’s, Work Instructions, Change Controls, Deviations, CAPA’s and other documentation requirements e.g. Risk Assessments etc.
- Recruiting, training, developing, coaching, and directing a team of professional auditors located in both regions.
- Support the Endo enterprise as a compliance SME. The individual should have an expert knowledge of the FDA, Health Canada, and EU regulations along with ICH guidance documents along with any other regulations that may affect drug and combination product manufacturing and distribution.
- This individual applies expertise in cGXP’s, international regulations and guidelines to the auditing process to independently address a variety of compliance issues associated with New Product development and commercial drug manufacturing.

Job Description

Responsible for the India auditing team members in maintaining the GxP auditing program encompassing all elements of Endo’s internal and external supply chain and manufacturing technologies where internal or external supply chain manufacturing occurs, Monitoring the Inspection Readiness of internal manufacturing locations and support functions. Responsible for the Compendial Review program team members.

• Oversees and directs the India based teams who are responsible for completing the external Quality auditing program of in-line and prospective CMOs, API suppliers and critical starting material suppliers for all Endo Subsidiaries.
• Oversees the output and adherence of the Compendial program.
• Oversees and directs the external auditing programs to ensure that the products, controls, policies and processes meet Pharmaceutical/Biotechnology industry quality standards.
• Oversees and directs the Due Diligence, New Vendor Qualification and Mock Pre-Approval Inspection programs for the new product development and launch programs.
• Oversees and directs the collection, collation, evaluation and publication of key auditing performance indicators in terms of external Auditing program execution, audit findings, and trends.
• Leverages lean management principles in establishing real time reporting and management of the auditing program.
• Establishes and maintains a standardized and consistent applied risk based rating approach to external auditing program observations classification approach and links to appropriate regulatory and industry standards: Code of Federal Regulations; FDA Draft and Final Guidance Documents; ICH, ISO, IPEC, Eudralex Vol 4, Health Canada GMPs; DSCSA and Falsified Medicines Directive etc.
• Evaluates all inspection program reports for consistency.
• Establishes and maintains escalation processes to assure the “within audit” and “post audit” reporting of potentially critical observations to appropriate stakeholders. Escalates to Senior and Executive level management as needed.
• Oversees and directs the establishment and maintenance of procedural and electronic Quality Management Systems for the planning/ arrangement, recording, review, approval and tracking of status of External and Regulatory inspections, observations, responses, and corrective and preventative actions.
• Oversees and directs the establishment and maintenance of manual and electronic record keeping related to Internal, External and Regulatory inspections, observations, responses, and corrective and preventative actions.
• Conducts audits and inspections as required to achieve the external and internal audit program
• Maintains and continuously improves the selection, training and development of the US and EU Auditing teams to assure the on-going effectiveness of the auditing program for the core manufacturing technologies and supporting engineering, facilities and equipment: Solid Oral Dosage; Non Sterile Semi-Solids and Liquids; Sterile Injectable Products; Biologic and Polypeptide API manufacture Chemical API Manufacture; Combination Products Manufacture; Bioequivalence/ Bioanalytical and GLP; Chemical, Biological and microbiological Laboratories; packaging and general GxP Quality Management Systems.
• Supports when required the wider EQA group based in India and manages guest auditors when required to support the EQA auditing program.
   Identifies and supports opportunities for personal and career growth within the Auditing function.
   Directs, Oversees, and maintains the Auditor qualification and requalification program for the EQA Global Group.
• Provides effective leadership and management of Audit Function staff in alignment with corporate HR policies and procedures and other relevant company and local employment regulations.
• Coaches and supports Auditors by applying Gemba principles for auditing execution with the mindset applied from Kaizen philosophy
• Monitors and analyzes CMO and externally regulatory observations, Regulatory Agency Guidance Changes and Emerging Industry Compliance Trends to identify emerging trends and potential strategic priorities to support the company objective of all sites being permanently inspection ready and receiving no major inspection observations.
• Provides written and verbal guidance to Senior Quality, Operations, Technical, Research and Regulatory Affairs Management on emerging trends and potential risks identified from the auditing and external inspection activity reviews.
• Establishes a network of trained Guest Auditors that can be drawn from internal sites to supplement the available dedicated auditing resources and provide rapid succession activity in the case of employee turnover.
• Participate as requested by Senior Quality Leadership in Regulatory Agency Audits in support of the site Quality Functions.
• Sponsors and supports continuous improvement projects related to EQA’s processes and systems and also to the wider Endo organization as a compliance SME.

Education & Experience

• Minimum of a M.Sc. / m. Pharma with a minimum of 15 years or longer experience in a pharmaceutical manufacturing or Quality Assurance/Compliance environment.
• A minimum of 10 years auditing experience associated with a wide range of Pharmaceutical Manufacturing Environments across multiple countries.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.