Director Enterprise Quality Auditing

4 weeks ago

Woodcliff Lake, United States Endo USA, Inc. Full time

Description

Responsible for the US and EU 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.

Auditing Program Management 40%

Oversees and directs the US and EU 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 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.


Auditing Quality Management Systems 20%

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.


People Coaching, Management Training & Development 20%

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.


Strategic Direction & Action 20%

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.

Qualifications

Minimum of a BA/BS with a minimum of 15years 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. Demonstrated effective people management and development experience.  ASQ-CQA or ASQ-CQE certified highly desired. QP and or/ RP experience highly desired

Knowledge

Possesses current and in depth knowledge of current and emerging quality/compliance regulations across multiple jurisdictions(e.g., cGMP, GLP, ICH guidelines and guidance documents) and a broad range of manufacturing technologies (API, Biologics, sterile manufacturing a minimum Combination Products ideal).

Possesses current and in depth knowledge of current and emerging Regulatory Agency inspection trends across multiple jurisdictions and manufacturing technologies.

Knowledgeable of and familiar with current IT based Quality systems.

Skills & Abilities

Effective at analyzing information and data and synthesizing situational appraisals and recommendations for actions with respect to quality and compliance issues emerging from internal, external and regulatory inspection activities.

Effective at analyzing cGMP regulations from multiple jurisdictions and synthesizing situational appraisals and recommendations for actions with respect to quality and compliance procedures and practices within the company to stay abreast of these issues.

Demonstrates Situation Leadership Skills and is effective at leading Cross Functional/ Multi-location initiatives associated with compliance and permanent inspection readiness improvement activities for the company.

Effective people developer and coach for direct reports, line staff and also “guest Auditors”.

Excellent communication skills,both written and verbal.

Effective at building effective relationships with external manufacturing service providers to support the company audit and compliance improvement programs.

Familiar and competent in the use of current Office and Shared working Space and Quality Management Systems IT products.

Physical Requirements

Able to walk across factory / warehouse spaces over multiple consecutive days of auditing with gowning and re-gowning including for entry into sterile facilities

International Travel (25%).

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.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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