GMP Operational Quality Senior Manager

BioPharma Consulting JAD Group; Boston (MA); On-site; USD 150,000 - 220,000; Full time

Benefits offered by this job

1 year contract with possible extend

Administrative shift

Job summary

BioPharma Consulting JAD Group seeks a GMP Operational Quality Senior Manager to lead QA/quality assurance for drug substances, drug products and devices. You will coordinate complex projects, resolve issues with CMOs and suppliers, and oversee investigations, CAPA and risk management programs.

The role requires deep cGMP expertise in biologics and devices, extensive experience with change control, audits and document systems (QDocs, TrackWise, Veeva).

Qualifications

• 8 years of experience in QA GMP in biologics and devices.
• Experience with contract manufacturers and continuous improvement.
• Experience with quality risk management best practices.
• Experience leading investigations, RCA and CAPA.
• Experience with electronic document management systems.

Responsibilities

• Collaborate with partners to resolve complex quality issues.
• Participate in cross-functional teams as QA resource.
• Draft and enforce Quality Agreements with CMOs/Suppliers.
• Assist Change Control owners and assess changes.
• Lead investigations, CAPA, and root cause analyses.
• Review master and executed batch records for DS/DP/FG disposition.
• Support internal and external audits.
• Identify risks and mitigation plans.

Skills

cGMP knowledge

GMP compliance

CAPA management

RCA

Quality risk mgmt

QMS tools

Document control

Vendor management

Education

Bachelor's degree in science

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