As the Manager, Quality Assurance you will be involved with clinical internal manufacturing campaigns and external Contract Manufacturing Organizations (CMO). You will be responsible for ensuring drug substance product quality, lot disposition, CMO QA relationship(s), and supporting manufacturing operations. This individual will represent Quality Assurance in cross-functional teams, such as CMC meetings and technology transfer(s). Brining a deep understanding of quality principles, you will play a critical role in the evaluation of quality issues, change controls, and process improvements. In this dynamic role, you will have the opportunity to have an impact on clinical material and aide in the commercialization of Acelleron's pipeline.
What will you be doing?
Oversee all aspects of Drug Substance Manufacturing operations internally and externally, including but not limited to batch record review, manufacturing support, QC support, deviation investigations, change controls, Quality agreements, and SOP and master batch record review.
Partners with Technical Operations, QC, Regulatory, Supply chain, etc, to ensure alignment with Manufacturing and support functions in executing the quality strategy/deliverables.
Acts as the lead SME for significant quality/compliance issues within Drug Substance Manufacturing.
Develops directs, and maintains quality systems in support of manufacturing in a manner consistent with Acceleron requirements and standards and current regulatory requirements.
Responsible for release of clinical and commercial batches.
Provide QA support for internal and external project and team meetings.
For significant issues, interfaces with internal and external groups for resolution of quality issues.
Has decision-making authority for all Quality issues; escalates critical issues in a timely manner.
Builds and maintains expertise in the QA operations team, ensuring development of staff.
Applies quality/manufacturing experience to ensure that operations meet regulatory expectations.
What are we looking for?
An energetic professional with strong knowledge of FDA, ICH, and EU GxP Regulations and Guidelines and a proven track record supporting CMC timelines.
A team player with a willingness to collaborate within QA and cross functionally on projects as needed
Strong project management skills with an eye for detail.
Effective written and oral communication skills; ability to successfully interact with both internal and external stakeholders.
Demonstrated critical thinking, decision making and analytical skills.
Ability to independently analyze complex quality events and drive to root cause(s) & CAPA(s).
Experience with MasterControl and/or Veeva a plus.
Preferred experience with Drug Substance manufactured at CMO's
Bachelor's degree in Science or technical discipline with +8 years of experience
Willingness to travel both domestically and internationally (10%)