Senior Auditor, Auditing and Due Diligence

SUMMARY OF POSITION

Responsible to organize, conduct and manage independent and objective quality audits (including for cause audits) of all Alvogen GxP suppliers and third party manufacturers (sterile and non‑sterile), and service providers that have a GxP impact (drug product, combination product & medical device related), as well as undertaking corporate quality audits of Alvogen manufacturing sites and operational units and support organizations with GxP impact, (excluding GCP & PV audits). Responsible to conduct and manage such GxP audits in line with Alvogen's corporate policies and procedures/guidelines, as well as regulatory requirements, including but not limited to U.S. FDA, EU, PICS, USP, WHO and ICH GxP regulations, guidelines & relevant ISO standards. May be assigned responsibilities to create, negotiate, revise, handle and approve assigned GxP quality agreements, to support Alvogen's sites, including third‑party quality organization, as well as Norwich Pharmaceuticals Limited and any other future Alvogen site/affiliate. Strive to work with all Alvogen business groups and internal departments to ensure a robust quality supply chain that acceptably supports and satisfies patient's & market needs as they relate to the supply of sterile and non‑sterile human drug products, combination and medical device products.

ORGANIZATION STRUCTURE

This position primarily interacts with Managers, Senior Managers, Directors and Sr. Directors, to support GxP auditing & due diligence support needs and supplier quality agreements (if necessary).

RESPONSIBILITIES

Plans and executes quality audits to the defined Alvogen policies & standards, as well as in line with regulatory legal requirements and expectations. Works with the Quality, Operations, Supply Chain, Business Development, R&D and Legal to plan audits of GxP 3rd party manufacturers, material & service providers and Alvogen operational sites and units located throughout the globe as necessary. Documents all audit findings within a formal Audit Report within the Company set timeframes. This includes, audit findings, and recommendations for improvement or correction. Follows up with the auditee to ensure that a suitable and acceptable corrective and preventative action plan is submitted to Alvogen. All such reports and CAPA plans to be reviewed/approved and archived within the pre‑set Alvogen audit report database. As needed or during the conduct of future audits of suppliers, manufacturers and Alvogen sites/operational units, to follow up on any Corrective and Preventative Actions from previous audits and to ensure adequate and timely closure. Handling and affording the necessary response to all Alvogen internal and external customers concerning audit related queries. Supporting Quality, Operations, Supply Chain, Business Development, R&D and Legal with Quality due diligence of potential new sterile and non‑sterile suppliers and third‑party manufacturers, and service providers via the conduct of associated support GxP audits. Keeping abreast of the requirements and the latest GxP trends as well as to ensure that Quality Management System policies and procedures related to supplier and Alvogen site/unit audits satisfy regulatory and legal requirements and expectations. Assist with the preparation review and approval of Standard Operating Procedures (SOPs) and Forms / Questionnaires for activities related to GxP auditing, and others as required. Provides and assists with training of other corporate quality auditors and assigned Subject Matter Experts (SMEs), as and when required. Identifies and leads quality improvements for quality systems, procedures and documentation associated with GxP auditing. May be requested to assist in establishing & maintaining assigned Quality Agreements with suppliers/manufacturers and service providers (GXP services/products/materials), for Alvogen, making use of in house quality agreement templates. Any other quality management activity that is reasonably requested by management pertaining to GxP Auditing.

QUALIFICATIONS

Preferably B.Sc. or higher degree in pharmacy, life science, process engineering or similar. Thorough knowledge of pharmaceutical industry, quality systems, GMP and GDP, and good understanding of GCP, GVP and GLP requirements. To be well acquainted with the U.S. FDA & European regulations and guidance documents on Good Manufacturing and Distribution Practices (cGMPs & cGDPs), ICH standards, PIC/s, ISO standards, as well as other applicable international GxP standards. Not less than 10 years of uninterrupted work experience in the production, QA and/or control of human pharmaceuticals (drug, combination and medical device products, or combination thereof). Minimum of 5 years sterile auditing experience is required (drug/combination products & medical device products). Lead Auditor Training Certification – ISO 13485:2016 (QMS / Medical Devices) and/or MDSAP Requirements is required. Thorough knowledge of Quality Systems and risk‑based decision making. Practical and hands‑on experience of auditing both external/internal companies, contract manufacturers and other GxP service providers. Previous experience with setting up and negotiating supplier quality agreements would be considered an asset. Experience and skills in operating across and between different national cultures. General computer use, e.g. Microsoft Office Programs.

SKILLS

Skill in researching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data. Skill in analyzing and troubleshooting problems, identifying potential solutions, recommending and implementing methods, procedures and/or techniques for resolution. Skills in communicating clearly and concisely, both orally and in writing. Good presentation skills. Skills in training / mentoring other auditors or designated SME support persons in sterile and non‑sterile auditing. Good interpersonal and excellent communication skills. Good negotiating skills. Working knowledge of the English language, written and verbal. Able to work proactively and independently. Ability to travel 40‑50% of time, primarily within the U.S. / North America.

GMP DECISION‑MAKING AUTHORITY

Person has responsibility to discuss, agree upon GxP audit commitments with GxP suppliers and service providers servicing/supplying Alvogen. Furthermore, deciding and assigning qualification status to GxP suppliers/service providers, following the conduct of GxP audits. If required, may directly set up, negotiate and follow up assigned quality agreements with Alvogen's suppliers/service providers. The anticipated base salary range for this position is $135,000-$142,000. This position is eligible for Alvogen's annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts. Alvogen's benefits package also includes a retirement savings program, long‑term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program. An Equal Opportunity Employer, including disability/vets. #J-18808-Ljbffr Norwich Pharmaceuticals