Quality Assurance Manager/Director
- Plans audit calendar, lead external and internal audits
- Provides "man-in-the-plant" observation/feedback at key manufacturing milestone activities
- Reviews and assesses complaints, deviations, quality events, investigations and CAPA activities at manufacturing sites; lead internal investigations
- Reviews and approves batch records, change controls, investigations and validation documentation; reviews Annual Product Reviews
- Provides Quality Assurance input to CMC and Clinical project teams, as required
- Reviews and negotiates Quality Agreements
- Develops with the CMC team and CMOs (and Marketing, as appropriate): DS, DP, Key Raw Material & Intermediates specifications and stability requirements; Master Batch Records; validated manufacturing processes and analytical methods; CTM and commercial packaging and labeling
- Monitors release and stability data
- Assists in build-out, management and continuous improvement of the Quality Management System and SOP System
- Conducts Material Review Boards, as required
- Tracks Quality metrics
Experience & Education Requirements
- Hands-on auditing experience in GMP and GCP environment, GLP a plus
- Knowledge of tableting and capsule equipment and non-sterile manufacturing
- Knowledge of US & EMA &ICH regulations/guidance for CMC and GMP/GCP
- Analytical, hands-on & attention to detail - ability to work independently and with a multi-disciplinary team - understands quality principals
- 7+ years in pharmaceutical Quality Assurance
- Science, Math or Engineering degree
Boston Biomedical is an industry leader in the creation and development of next generation cancer theraputics. Our most advanced program involves inhibitors of cancer stem cell pathways. Cancer stem cells have been shown to contribute to both recurrence and metatasis. Because cancer stem cells are thought to be resistant to current chemotherapies, we believe that focusing on stemness pathways may hold promise for advancing cancer treatment. In addition to our advanced cancer stem cell pathway inhibitor program, we have several compounds, which include peptide vaccines and immune response modifiers, in preclinical and early clinical development.
Boston Biomedical is a fully integrated oncology drug research and development company with expertise in drug discovery, crystallography, medicinal chemistry, preclinical development, pharmacology, pharmaceutical development, CMC (chemistry, manufacturing and control), global clinical trials and regulatory affairs. Our scientists have established a track record of accomplishments in a short time, including the discovery and ongoing development of multiple compounds and programs.
As our compounds moved forward in development, we began building out our commercial operations group in 2013.
Boston Biomedical has created a unique corporate work environment. We aim to continue to leverage our innovation-driven culture, scientific leadership and drug development expertise to advance the development of novel cancer therapeutics for patients with cancer.
Thu, 11 May 2017 13:29:13 PDT