Allergan Assoc Dir, External Audits in Parsippany, New Jersey
Assoc Dir, External Audits
Parsippany, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/168/other-jobs-matching/location-only
▾ ▸ 1 additional location
Jersey City, New Jersey, United States
Oct 10, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
This position will be responsible for planning and conducting all the external audits such as Contract Manufacturers, API Suppliers, Excipient Suppliers, Primary and secondary packaging components, printed materials, suppliers, warehouses, around the globe. This person should be knowledgeable not only in the EU/MHRA regulations, directives, and guidance, but also in other global regulations, directives and guidance such as FDA, Health Canada, Brazilian (ANVISA), Australia (TGA),New Zealand (Med Safe), WHO, ICH and other applicable country regulatory requirements.
Additional responsibilities will include:
Responsible for developing external audit program and execute with appropriate procedures and reports in compliance with changing global regulatory requirements and conduct some key audits as assigned by the head of Global Compliance department. Risk assessment and mitigation activities related to contractors and suppliers. Managing the direct reports (10) including personnel located at international locations and responsible for the administration of their job functions. Support the completion of special projects/goals and tasks as assigned. Planning the annual external audit/unplanned schedule and responsible for assigning auditors according to their skill sets and establish regular communication via meetings with Global R&D, Global Procurements, Manufacturing site, Contract Manufacturing Quality (US & ROW), Business Development, Legal, and other applicable departments with regard to applicable audits and alert any supplier related issues as appropriate to the head global compliance for further action. Train, coach, and approve auditors to meet all applicable regulatory requirements. Responsible for the maintenance of allocated travel budget and provide support to the head of department for developing strategic budget for the global audit program. Attend other tasks assigned by the head of the Global Compliance department.
Qualified candidates will have the knowledge ofsupplier/contractor audits at a global level, which have an impact on Global supply chain, Global regulatory, Global business development, Global R&D and global procurement and also influences the timely delivery of regulatory application submissions for multiple regulatory markets. This requires good understanding of the above functional roles and urgency of their tasks. Communication in timely manner is essential to run the business smoothly.Understanding of the risk to business by a disqualified supplier(s) and the potential impact on compliance should be carefully evaluated by the person who is holding this position.Internally with R&D, Site heads, Contract manufacturing quality, global procurements, EU QPs, Regulatory affairs, Pharmacovigilance, Business developments in relation to seeking information regard to supplier information, communicating the audit outcome and the potential compliance risk, in the event of unacceptable audits, recommend alternatives and provide advice on concerns. Excellent communication (oral & written) and interpersonal skills.
Candidates will have aBachelor of Science 10 years in pharmaceutical or biologics/medical device with QA/Compliance and strong knowledge in global regulations with FDA & EU and interpretation of such regulations a must. Certification in Auditing preferred.