What are the responsibilities and job description for the QA Manager, External Manufacturing position at Raise?
QA Manager, External Manufacturing (Remote)
- Salary: $97,000 – $125,000
- Location: Remote
- Urgency: Immediate hiring need (replacement for retiring incumbent)
About the Role
We are seeking an experienced QA Manager, External Manufacturing to provide quality oversight and ensure compliance across third-party manufacturing partners. This role is critical in supporting the lifecycle development and commercialization of pharmaceutical products, with a strong focus on cGMP compliance, regulatory standards, and quality systems.
You will act as the primary quality contact for external partners and play a key role in maintaining product quality, regulatory compliance, and operational excellence.
Key Responsibilities
- Lead quality oversight for external manufacturing partners (CMOs) and cross-functional teams
- Ensure compliance with cGMP, regulatory requirements, and quality agreements
- Serve as the Quality lead for technology transfers and commercial production activities
- Review and approve quality documentation including:
- Change controls
- Batch records
- Validation and stability reports
- Investigation reports
- Approve and release commercial products based on compliance and specifications
- Lead investigations related to deviations, non-conformances, and product complaints
- Drive CAPA (Corrective and Preventive Actions) and ensure timely closure
- Monitor and report quality metrics and supplier performance
- Support regulatory inspections and maintain inspection readiness at partner sites
- Conduct risk assessments and implement continuous improvement initiatives
- Participate in cross-functional teams and external partner meetings
Qualifications
- Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Chemical Engineering)
- 5 years of Quality Assurance experience in pharmaceutical manufacturing
- Experience working with Contract Manufacturing Organizations (CMOs) or external partners
- Strong understanding of:
- cGMP regulations
- FDA and EU guidelines
- Quality Management Systems (QMS)
- Experience with generic pharmaceuticals is highly preferred
Preferred Qualifications
- ASQ Certified Auditor (nice to have)
- Strong knowledge of regulatory trends and global compliance standards
- Experience with quality systems, audits, and supplier management
Skills & Competencies
- Strong communication and stakeholder management skills
- Ability to manage multiple projects and priorities
- Risk management and problem-solving mindset
- Proficiency with Microsoft Office and electronic QMS systems
Additional Details
- Travel: Up to 25% (domestic and international)
- This is a high-impact, hands-on role with significant cross-functional collaboration
Looking for meaningful work? We can help
Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity.
We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.
We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation:
https://raise.jobs/accommodations/
In order to submit candidates for roles, our clients will sometimes require personal information to confirm the identity of applicants and their legal status to work. Raise will never ask you for personal or banking information unless you have been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at 1 800-567-9675 or hello@raiserecruiting.com
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Salary : $97,000 - $125,000