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We're looking for a Quality Manager V
, working in Pharmaceuticals and Medical Products
industry in 225 2nd Avenue, Waltham, Massachusetts, 02451, United States
- Provide quality oversight of cGMP external drug substance manufacturing operations.
- Provide quality guidance and support for investigations and change controls.
- Provide support of process performance qualification activities including document review and approval.
- Provide support of product stability programs including document review and approval.
- Perform review/approval of master production records, executed batch records and disposition of product.
- Provide quality support for clinical and commercial technology transfers to CMOs.
- Provide support of Quality Management Systems, as needed - e.g. product quality reviews, data compilation and analysis, audits, risk program.
- Provide PAI readiness support including on-site support of CMOs, as needed.
- Travel, as needed to CMOs to support products.
- Participate in routine internal and external Operations Meetings.
- Escalate quality and compliance issues to quality management.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Education and Experience:
- Bachelors degree is required
- Minimum 8 years pharmaceutical / biotechnology industry experience
- Minimum 4 years experience within a Quality role
- Demonstrated success in working cross-functionally in a matrix organization
- Experience working with external partners (e.g. CMOs, contract laboratories and suppliers)
- Demonstrate strong leadership capabilities, but also the ability to actively listen
- Experience with biologics drug substance manufacturing processes
- Ability to influence in a matrix organization
- Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach
- Manage through ambiguity, work independently and prioritize the workload with minimal direction
- Exude a passion for relationship building both inside and outside the company
- Demonstrate excellent communication skills both internally and externally
- Ability to multi-task and work in a fast paced and dynamic environment
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?