The GMP Operational Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. This role coordinates or executes activities on multiple complex projects with emphasis on QA GMP disposition of drug products and devices.
Responsibilities:
- Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
- Participates in cross-functional teams as an experienced Quality technical resource
- Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
- Assists Change Control owners with ensuring compliance to change procedure requirements
- Initiates and assesses change controls
- Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
- Ensures appropriate CAPA actions are identified and addressed.
- Approves investigations/CAPAs.
- Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP) and finished goods (FG) disposition activities
- Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems
- Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
- Identify and communicate risks and assist with risk mitigation plans as necessary
- Supports internal audit or external audit programs
Requirements
- Bachelor's degree in a scientific or allied health field.
- 8 years of experience.
Must have:
- In- depth knowledge of both the conceptual and practical application of cGMPs in a biologics + devices pharmaceutical setting; in-depth knowledge of global GMP requirements in support of GMP Drug Product manufacturing
- Experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines
- Experience in identifying, assessing and mitigating potential risks utilizing quality risk management best practices
- Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)
Benefits
1 year contract with possible extension
Administrative shift
Skills Required
- Bachelor's degree in a scientific or allied health field
- 8 years of experience
- In-depth knowledge of cGMPs in a biologics and devices pharmaceutical setting
- In-depth knowledge of global GMP requirements supporting GMP drug product manufacturing
- Experience managing complex projects with contract manufacturing organizations
- Experience with continuous improvement within stated objectives and timelines
- Experience identifying, assessing, and mitigating risks using quality risk management practices
- Experience leading event investigations, Root Cause Analysis, and CAPA
- Experience with electronic document management systems such as QDocs, TrackWise, or Veeva
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
