Apicore US LLC headquartered in New Jersey, USA, and its contract manufacturing organization, Apicore Pharmaceuticals Pvt Ltd (Gujarat, India) are dedicated to developing and manufacturing active pharmaceutical ingredients (APIs) at our facilities, located in Somerset, NJ and Gujarat, India for the worldwide pharmaceutical industry.  We are a rapidly growing company with double digit growth rate year after year with exponential growth possibilities due to our recent initiatives to expand. We are currently in search of a Vice President of Global Quality to join our growing team.

 

The Vice-President of Global Quality will be reporting into the CEO of the company and will be responsible for Apicore US LLC and will be overseeing Apicore Pharmaceuticals Pvt. Ltd. quality unit. This position is an integral part of the senior management team involved in strategic decision making and compliance with regulatory bodies. This position will be based out of our headquarters in Somerset, NJ.

 

Duties and Responsibilities will include but are not limited to the following:

 

• Create a quality organization and systems that will provide the company with a competitive advantage in the market place.
• Provide effective leadership and direction for the quality programs throughout the company’s manufacturing operations on a global level.
• Provide structured review processes to report data on a monthly/quarterly basis to the CEO and Board of Directors.
• Directs efforts to ensure efficient and effective deviation, CAPA, training, and document control systems are maintained and continuously improved.
• Ability to lead, influence, create and work within cross-function team environments.
• Able to work on multiple projects simultaneously and adapt to fast changing business priorities.
• Serve as a key and active member of the team to ensure business objectives are aligned and that the company is performing to its operational objectives.

 

Qualifications

 

• The ideal candidate must be a team player with a very positive attitude in working with multiple departments who are staffed with a mature and sensible workforce.
• Eight to ten (8-10) years’ experience in the pharmaceutical arena.  Multisite responsibility is desired.
• Experience in manufacturing and quality control experience with APIs and formulation is preferred.
• Must have strong knowledge of cGMP (FDA/EU and ICH) requirements and the ability to assess compliance risks.
• Extensive experience in regulatory inspection management programs and participating in regulatory inspection audits.
• Motivational leadership skills and adept problem solving abilities.
• Demonstrates excellent verbal, written, and interpersonal communication skills throughout all levels of the organization.

 

Apicore US LLC offers a competitive salary and benefits package and the opportunity to work within a dynamic environment. Interested individuals are encouraged to submit a cover letter stating their salary expectation along with a detailed resume to:  jobs@apicore.com

 

Principals only. Recruiters please do not contact. Do NOT contact us with unsolicited services or offers