Recipharm · 2 days ago
Manager, Quality Assurance Operations
Boston, MA
Full-time
Onsite
Mid, Senior Level
$135K/yr - $175K/yr
7+ years expRecipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. The Quality Assurance Operations Manager is responsible for overseeing quality operations activities, ensuring compliance, managing personnel, and driving continuous improvement initiatives within the quality assurance department.
BiotechnologyHealthcareManufacturingPharmaceuticalMedical
Responsibilities
Hire, develop, and train department personnel to support Quality Assurance Operations responsibilities and career growth
Actively participate in fostering a positive, collaborative work culture
Ensure adherence to cGMPs across the organization
Manage incoming material release, product batch record review, lot disposition, review of process validation protocols and reports
Manage the deviation program and lead investigations, including deviations, CAPAs, and complaints
Ensure timely lot disposition and deviation closure
Report quality system metrics, lead CAPA investigations, and drive continuous improvement initiatives
Foster and develop intra- and inter-departmental relationships including collaboration with global teams to implement best practices
Support internal and external audits, including preparation of audit reports and responses
Participate in developing project plans
Evaluate and mitigate program risk and escalate quality issues as needed
Provide Quality Assurance input and oversight for clinical and commercial projects, including technical transfers and the stability program
Support internal audits, customer audits, and regulatory inspections
Support Quality Management Reviews
Partner with site leadership and global Quality teams to align local quality systems with corporate and regulatory expectations
Recruit, hire, coach, and train employees within the QA operations group
Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources
Set clear performance expectations, provide regular feedback and coaching, and manage performance in alignment with company objectives
Qualification
Required
B.S. degree in science or a life science-related field of study
7+ years of experience in Quality Assurance in a GMP-regulated environment
Minimum of 3 years of people management experience, including direct report leadership
Strong knowledge of FDA, ICH, and EU GxP Regulations and Guidelines
Experience with ensuring alignment with relevant guidance and regulations
Experience with root cause analysis, CAPA and internal audit systems
Experience working with Risk Management and New Product Development
Management of major and critical investigations, complaints, and CAPAs
Involvement in continuous improvement initiatives
Proficiency in Microsoft Office suite applications
Experience working with electronic quality management systems (eQMS) and document control systems
Preferred
Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience preferred
Company
Recipharm
Recipharm focused on supporting pharmaceutical companies in taking their products from early development to manufacturing.
5001-10000 employees
H1B Sponsorship
Recipharm has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$241.75MKey Investors
Bill & Melinda Gates Foundation
2025-01-13Grant
2016-01-27Post Ipo Equity· $32M
2014-09-19Post Ipo Debt· $209.75M
Leadership Team
Magnus Renck
VP - Operations Development
Marc Funk
Board Member
Recent News
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