Manager/Sr. Manager Quality Assurance-Global Pharma Co Opening US HQ in NJ: Cornerstone Search Group, LLC

Manager/Sr. Manager Quality Assurance-Global Pharma Co Opening US HQ in NJ

Summary: Provide Sr. Management members of the U.S. affiliate and the Parent Company with advice and guidance regarding complying with US FDA regulatory requirements for its multiple approved and marketing FDA drugs.

Location: Morristown, NJ Area

Attractive Features About This Company:

• Join an established billion dollar international pharmaceutical industry leader opening its first USA Headquarters in NJ.
• Join an established international pharmaceutical company opening its first USA Headquarters that already has multiple FDA approved drugs marketed in the USA generating several hundred million dollars in annual revenue.
• Join an international pharmaceutical company that generates a very strong profit.
• Very attractive opportunity to "get in" on the ground floor of this company as it starts to build its USA team

Attractive features about this position:

• High exposure position: you will interact directly with multiple Sr. Management team members of the US-based company and the internationally-based parent company.
• Make a difference: you will be the first Quality Assurance/Regulatory Affairs professional in the company where you will be able to see the actual impact of your advice, guidance, decisions and actions.
• Challenging and diverse responsibilities: your responsibilities will be broad and range from overseeing SOPs to handling customer complaints to communicating directly with FDA representatives.
• Ground floor opportunity: you will be the first Quality Assurance/Regulatory Affairs professional hired by the company and thus will have an opportunity to create the first set of footprints for the position.

Responsibilities:

Work closely with Sr. Management members based in the US and abroad to appropriately handle (i.e. comply with both company standards/SOPs and regulatory requirements) customer complaints. This position’s responsibilities will include, but not be limited to, performing the following:

• Handle customer complaints directly communicated to the company and/or FDA about the company’s pharmaceutical drugs/products. Note: the complaints this position will handle will mostly deal with drug/product packaging and manufacturing. And, this position will not be responsible for complaints dealing with drug/product efficacy and adverse events.
• Develop, enhance and modify SOPs, processes and systems necessary to capture, handle, resolve and report customer complaints.
• Communicate directly with customers (e.g. Pharmacists, Patients and Practitioners), FDA representatives and manufacturing personnel to handle and resolve customer complaints.
• Identify, investigate, analyze and report any significant customer complaint trends.

Requirements:

• BA/BS degree in one of the life sciences
• 5 or more years of experience gained working in the Pharmaceutical/Biotechnology industry
• Several years of experience directly handling customer complaints (e.g. complaints received from Pharmacists, Patients, Practitioners and complaints communicated directly to the FDA by one or more of the aforementioned) about pharmaceutical drugs/products. Note: the complaints this position will handle will mostly deal with drug/product packaging and manufacturing. And, this position will not be responsible for complaints dealing with drug/product efficacy and adverse events.
• Experience developing and enhancing SOPs, processes and systems for capturing, handling, resolving and reporting customer complaints is highly desired.
• Good communication skills (verbal and writing skills)
• The ability and willingness to travel domestically and internationally as required

Cornerstone’s Privacy Policy

Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information. Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission.

Contact:

Cliff Miras (initial contact via email is preferred)

Co-founder & Managing Partner

Cornerstone Search Group, LLC

6 Campus Drive

Parsippany, NJ 07054

P 973-656-0220 ext 711

Email Steven Raz or Research Team: cmiras@cornerstonesg.com or ResearchTeam@cornerstonesg.com

Web/URL: www.cornerstonesg.com

About Cornerstone Search Group, LLC

Cornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets.

Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates.

Building better companies. Building better careers.®

Other Opportunities

Cornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist. Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.

Keywords: Quality Assurance, QA, Quality Control, QC, Regulatory Affairs, RA, Standard Operation Procedures, SOPs, Customer Complaints