What are the responsibilities and job description for the Quality Assurance Operations Manager position at Beacon Hill?
The Quality Assurance Operations Manager is responsible for leading and overseeing all quality assurance activities within a regulated manufacturing environment. This individual ensures products are manufactured, tested, and released in full compliance with applicable regulatory requirements, cGMP standards, internal procedures, and site quality objectives.
This role provides both strategic and hands-on leadership for QA functions and plays a critical role in maintaining product quality, supporting inspection readiness, and driving continuous improvement across the site. The position reports to senior site quality leadership.
- Lead daily Quality Assurance operations, including In-Process QA (IPQA) and Raw Materials QA, ensuring compliance with regulatory and internal quality standards.
- Oversee batch record review and final product disposition, ensuring accurate and timely release of finished goods.
- Provide real-time quality oversight on the manufacturing floor, supporting GMP operations and ensuring adherence to procedures.
- Lead internal audits, customer audits, and regulatory inspections, including preparation and follow-up activities.
- Review and approve investigations related to deviations, non-conformances, and atypical events, ensuring thorough root cause analysis and effective CAPA implementation.
- Ensure execution of quality programs such as incoming material inspection, acceptance quality limits, and first article inspections, as applicable.
- Partner cross-functionally with Manufacturing, Quality Control, R&D, Maintenance, Regulatory, and Supply Chain to ensure quality is embedded in all processes.
- Author, review, and approve SOPs and controlled documentation to ensure compliance and clarity.
- Develop, coach, and mentor QA team members, fostering a strong culture of quality and accountability.
- Monitor site quality performance through KPIs, trend analysis, and risk assessments to drive continuous improvement.
- Maintain current knowledge of regulatory expectations and industry best practices.
- Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field.
- Experience in Quality Assurance within a GMP-regulated manufacturing environment (pharmaceutical, medical device, or related).
- Strong knowledge of FDA, EMA, and ICH regulatory requirements.
- Hands-on experience with batch review, product release, deviations, investigations, and CAPA management.
- Proven leadership experience managing or developing QA teams.
- Strong communication, problem-solving, and cross-functional collaboration skills.
Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.
California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com.
Benefits Information:
Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.
We look forward to working with you!
Beacon Hill. Employing the Future™