Senior Manager; QA Compliance-Investigations

Description

About CPC:

CPC management demonstrates strong ethics while promoting a culture that provides a sense of safety to our team. We empower our colleagues to self-organize, while encouraging a sense of connection and belonging. Management is open to new ideas, promotes organizational learning and nurtures personal growth from within. 

Recognized by Long Island Press and Dan’s Papers as a “TOP Long Island Workplace”, Contract Pharmacal Corp (CPC) is looking for new team members eager to build upon their current skill set. 

At CPC you are joining an extended family of 1,500 of the industry’s top professionals to bring best in class products to market. With over 5,500 dietary supplements, over-the-counter drugs and Rx pharmaceuticals already developed, CPC offers a dynamic and exciting work environment. 

Position Summary:

The Sr. Manager Quality Assurance Compliance - Investigations has primary responsibility for all activities related to oversight of personnel in support of conducting GMP Manufacturing, Packaging, Testing and Storage investigations and ensuring CAPA resolution.  

Responsibilities: Responsibilities include, but are not limited to: 

Investigation Programs:

· Direct Customer Complaint investigations, prepare responses and implement Corrective and Preventative Action (CAPA).

· Direct GMP Deviation investigations and implement CAPA 

· Direct Non-Conformance Report (NCR) investigations and implement CAPA

Training Program:

· Coordinate GMP and SOP training programs utilizing QMS Software

· Preparation and/or approval of training materials

· Monitor training metrics.

CAPA Program:

· Ensure timely completion of external audit CAPAs

· Monitor closure of internal CAPAs

· Monitor CAPA metrics 

General:

· Head the Quality Review Board (QRB) and Material Review Board (MRB)

· Oversee Product returns

· Oversee Product Withdrawals and Recalls   

Requirements

Education and Experience:

· Bachelor’s degree in science, compliance, or related required

· Master’s degree preferred

· 5 years of GMP managerial experience within pharmaceutical quality assurance and compliance.

· Preferred Certifications:

 Root Cause Analysis

Skills, Abilities and Knowledge:

· US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing

· Pharmaceutical Quality Systems

· ICH, USP, and EP Guidance 

· Analytical principles and manufacturing processes

· Data analysis

· Effective written and oral communication skills to all employee levels

· Excellent technical writing skills and attention to detail

· Ability to manage multiple tasks and meet deadlines

· Proficient in Microsoft Word, Excel, Power Point, Microsoft Office Outlook

· Required training in SOP, cGMP, and General Safety procedures

Physical Demands:

· Required to use hands to operate computer controls.

· Specific vision abilities required include close vision, ability to focus. 

Work Environment:

· Required to be present in the office to collaborate with directors, peers and other departments daily.

· Responsible for adherence to safety policies. 

· Flexible schedule to meet business requirements

Supervisory Responsibilities:

· Responsible for managing non-union employees

Personnel Protective Equipment or Attire Required for Position: 

· As needed