Piper Companies is looking for a Head of GMP Compliance in Boothwyn, PA to provide guidance to multiple departments (Engineering, Product Development/Technical Services, Production/Ops) and sites regarding their compliance to all applicable Quality and Regulatory Agency procedures, policies and regulations within our client's organization.
Responsibilities for the Head of GMP Compliance include:
- Monitor and drive corporate cGMP inspection readiness at all times through ensuring cGMP compliance to regulatory requirements as well as any other statutory rules applicable in the development, manufacturing and packaging of products. This at times requires making recommendations to change existing processes, equipment and or systems, sometimes at considerable cost to the company and / or company vendor partner.
- Participates in the evaluation of quality events, incidents and complaints. Keep up-to date with all related quality legislation and compliance issues.
- Leads, develops, implements and maintains quality strategies, procedures and systems in line with corporate business goals.
- Formulate quality compliance policies, guidelines and systems to ensure that the quality of the company’s products, processes and procedures are in compliance with all applicable cGMP regulations.
- Interpret and ensure compliance to applicable regulations, guidelines, and advising senior management on relevant business needs.
- Develop, implement and maintain periodic reviews of these systems and implement corrective actions as appropriate.
- Audit the vendors
- Raw material, packing material, contract testing laboratories, etc. as per in-house SOP to ensure that all the vendors are complying with cGMP standards.
- Capable to make decisions independently and collaboratively regarding status of audits and facility compliance
Requirements for the Head of GMP Compliance include:
- Bachelor’s degree in a life science or related field of study
- 1-2 years of experience in cGMP environment
- Minimum 10 years of experience quality and / or compliance oversight and auditing of all associated companies (providers, etc.) within the cGMP regulated environment, to include minimum of 3 years in a lead role or management position.
Please send resumes to Karen Pallone at firstname.lastname@example.org