Sr. Manager, R&D Quality Assurance GMP

Proclinical is currently recruiting for a Senior QA Manager with a global pharmaceutical company located in Philadelphia, PA. As the Senior QA Manager, you will support GMP Quality Assurance (QA) in maintaining Quality Systems related to clinical development including the manufacture and testing of clinical supplies for large and small molecules. The Senior Manager also ensures the control over the documentation required for regulatory submissions.

Job Responsibilities:

• Develop, implement, perform, and maintain Quality Systems and procedures.
• Act as a subject matter expert for EDMS and Quality Management System.
• Provide training when needed on the EDMS and Quality Management System.
• Manage CMO Quality relationships.
• Attend and be an active participant in technical project team meetings.
• Review cGMP documentation related to the manufacturing of drug substance product, drug product, packaging, and labeling for clinical use.
• Manage the execution, review, and/or approval process of all controlled documents, including SOPs, deviations, investigations, change requests, CAPAs.
• Assist with the notification, monitoring, and closure of internal and third-party investigations and complaints related to clinical supplies.
• Ensure timely routing and processing of all GxP documents.
• Disposition of drug substance, drug product, packaging, and labeling of supplies for clinical use.
• Accountable for entry of Quality Management System related information into applicable systems.
• Review Regulatory documentation, such as IND and IMPD, as well as responses to Health Authority questions if requested.
• Manage and track controlled document distributions to external CMO's.
• Negotiate Quality Agreements with third parties.
• Perform and support internal and external cGxP audits and activities as required.
• Provide support and participate in regulatory agency inspections.
• Identify internal and external Quality System issues and alert QA supervision.

Skills and Requirements:

• Bachelor's degree in scientific/life-sciences or related field.
• A minimum of 5-7 years' experience in the Pharmaceutical or Biopharmaceutical industry with at least 5 or more years' experience in an FDA quality/regulatory related function required.
• Thorough understanding of quality management systems and quality system practices in the pharmaceutical industry. Experienced with CMO relationship/Quality System management preferred.
• Experience with an EDMS, Training and Quality Management System. Strong detail orientation and focus on quality work product.
• Ability to manage and prioritize projects under tight deadlines.
• Ability to work under challenging deadlines and be accountable for completing work within specified project timelines.
• Strong written, oral communication, interpersonal, and organization skills.
• Strong computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.

If you are having difficulty in applying or if you have any questions, please contact Matt Tong at (+1) 646-878-6308 or m.tong@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.