Quality Assurance Risk Manager
Quality Assurance Cambridge, MA
Who are we? Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company’s leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body’s ability to regulate cellular growth and repair. Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchisewith two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with a Phase 2 trial of sotatercept planned in pulmonary arterial hypertension.
What’s in it for you?
In this role, you will be primarily responsible for building out and maintaining the riskmanagement quality system. Reporting to the Associate Director of Quality Assurance, you willensure compliance with applicable regulations with regards to sponsor oversight of Acceleron’s quality systems. Supporting multiple priorities and projects, our QA team is cross-trained in most areas. This means that in addition to your subject matter expert role in Risk Management, you will also play a significant role in broader Quality Systems support and continuous improvement.
What will you be doing?
- Leading and supporting teams in a matrix management environment, working towards proactive risk management
- Leading GxP Investigations to address quality events in a risk based manner
- Developing risk management programs and integrates them into quality systems
- Reviewing, organizing and providing guidance on validation and computer validation projects
- Providing QA support to CMC organization to ensure data is generated, documented (recorded), and reported in compliance with current Good Manufacturing Practice and the applicable requirements
- QA review of Batch Records, SOPs, Test Methods, and other CMC documentation as required
- Reviewing IND, CTA and other documents to support regulatory filings
- Planning and overseeing internal & external audits; Proactively identifying quality issues/discrepancies, and effectively resolving them in a flexible and constructive manner
- Providing QA support for CMO and CTL Oversight
- Providing QA support for Critical Quality Issues and vendor deviations
- Providing interpretation and guidance for internal and external customers on clinical quality related regulations/guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current cGMP standards
- Coordinating, developing, maintaining and/or providing cGMP training to personnel
- Participating in company preparations for regulatory inspections
- Providing GLP and cGMP support as needed
What are we looking for?
- The QA Manager should have a minimum of a four year technical degree or equivalent education and work experience
- Minimum of eight+ years’ experience in pharmaceutical, biotech or related health-care industry
- Minimum of six years’ experience working as a QA leader in a cGMP role
- Minimum of four years’ experience as a cGMP auditor
- The ability to organize, develop and manage risk based quality systems
- Must have excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines
- Demonstrates strong interpersonal communication skills, ability to work in team environment and excellent organizational skills