Cambrex
QA Compliance Manager
US-NC-Durham
Job ID: 2024-3667
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex - Durham
Overview
The QA Compliance Manager is responsible for the inspection readiness program for the assigned site.
Inspection readiness may include periodic internal audits, client audits, or any external agency
inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality
representative during external agency or client audits. Accountable to the client and/or agency for audit
observations responses and the associated corrective measures. or GMP/GDP audits (for Client,
Regulatory & Internal).
The QA Compliance Manager works collaboratively with other members of the site, and the client’s
functional areas and leadership teams to evaluate GMP/GDP business operations for compliance with
health authority requirements, SOPs, and procedures, to ensure product quality and patient safety
Responsibilities
- Reports to the Site Quality Head.
- Manages, leads, and supports client visits, client audits, regulatory audits and inquiries to ensure
complete fulfillment of requests and interests. Identifies the scope and associated audit team
member(s).
- Generate/Evaluate audit responses to audit observations and ensure that proposed CAPA plans are
suitable to address the observed deficiency and reduce risk to the business.
- Review evidence of CAPA completion and evaluate CAPA effectiveness during subsequent audits.
- Lead and drive continuous improvement of the audit program, and development of tools and
processes utilized to facilitate the audit process.
- Authors and negotiates terms of Quality Agreements with clients as needed.
- Oversees vendor management program, supplier certification and qualify GxP vendors, as needed.
- Investigates deviations/events, issues and manages Corrective/Preventative Actions. Participates in
creation and management of changes.
- Escalate issues to management in a timely manner implementing appropriate solutions, including
Corrective and Preventative actions.
- Interpret applicable quality regulations/standards and create appropriate policies and procedures.
- Maintain current knowledge of updated regulations; industry guidance; and best practices to ensure
optimal execution of the audit program.
- Works with the site management in all areas to maintain a cGMP compliant facility in a constant
state of inspection readiness.
- Facilitates the development, implementation, and maintenance of procedures and policies to
comply with FDA, EU, and ICH requirements applicable to site’s needs.
- Creates strong and effective working relationships with Quality team, colleagues and clients.
Qualifications
- Related BA/BS, required.
- 8+ years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in
Quality Assurance.
- At least 4 years of experience in a leadership role in pharma or biotech.
PI239207742
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