GMP Operational Quality Senior Manager

BioPharma Consulting JAD Group; Boston (MA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

1 year contract with possible extend

Administrative shift

Job summary

BioPharma Consulting JAD Group is seeking an experienced GMP Operational Quality Senior Manager to lead QA/GMP disposition of drug substances, products, and devices. You will coordinate cross-functional teams and collaborate with CMOs to resolve complex quality issues and ensure compliant solutions.

The role requires extensive knowledge of cGMPs in biologics and devices, with experience in investigations, CAPA, and risk management.

Qualifications

• In-depth knowledge of cGMPs in biologics + devices pharma setting.
• Experience managing complex projects with CMOs/partners.
• Experience leading investigations, RCA, and CAPA.
• Proven ability to manage quality risk and compliance programs.

Responsibilities

• Coordinate or execute QA/GMP disposition activities across multiple projects.
• Lead cross-functional teams to resolve complex quality issues and ensure compliant solutions.
• Draft and enforce Quality Agreements with CMOs and suppliers as needed.
• Support Change Control processes and assess deviations and CAPAs for adequacy.
• Review master and executed batch records for DS/DP/FG disposition.
• Contribute to risk assessments and communicate mitigation plans.

Skills

Quality Assurance

GMP Compliance

Risk Management

Cross-functional Leadership

Education

Bachelor's degree in Life Sciences or related field

Tools

QDocs

TrackWise

Veeva

Job description

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