The Senior Manager of Quality Control is responsible for lot release testing and Certificate of Analysis approval. This manager will oversee Boston Biomedical’s global contract testing laboratories in partnership with the Company’s CMC Team. They will be responsible for leading the Stability Committee and the Specification Committee for GMP Drug Substance and Drug Product programs.
They will ensure compliance to applicable global laws and regulations and participate in compiling and reviewing analytical sections of the IND and NDA submissions. This role works with internal stakeholders and external partners to ensure Quality released drug supply and expiring dating in is available to support clinical programs and future marketed product launch.
- Review and approve release and stability testing conducted at contract manufacturing and testing sites for oral (tablets and capsules) and sterile injectable drug products.
- Direct the optimization, validation and transfer of GMP analytical procedures for testing drug substance and drug product for release and stability testing.
- Manage partner relationships where the same drug product testing and stability may be shared across global programs and the company’s external partners to sustain global uniformity of analytical methods across labs.
- Support the oversight of Research and Diagnostic Biomarker contract laboratory testing and standards.
- Participate in cross-functional project teams to coordinate analytical activities at CMOs/CROs.
- Manage reference standard programs, oversee production, certification, inventory and distribution of reference materials.
- Trend and analyse data for release and stability using statistical software tools.
- Contribute to resolution of deviations and investigations, implementation of corrective / preventive actions and change controls.
- Enhance quality control practices and optimize internal processes by contributing to the preparation, review and approval of standard procedures and electronic systems.
- Author and review regulatory IND, NDA and CTD CMC sections including analytical procedures, method validations, reference standards, batch analyses, product characterization, stability and specification sections. QC submissions for accuracy and data integrity.
- Maintain collection of contract laboratory Certificate of Analysis and GMP stability procedures in the electronic Document Control System (Master Control).
- Audit contract laboratory sites and conduct annual Risk Assessments as part of the Supplier Quality program.
- Participate in the creation of Quality Technical Agreements for contract laboratories.
- Gather information from CMOs and contract testing laboratories for annual product reviews.
- Support a culture of quality across the company.
- Monitor industry and regulatory trends to ensure evolution of the Quality Control programs.
- Establish and maintain a positive working relationship within Boston Biomedical and with their external business partners as it relates to area of responsibility.
- Assist in the management of inspection preparations and hosting regulatory agency inspections.
- Other duties as needed.
- Bachelor’s degree in Quality Management or related science discipline required; Advanced degree (MS, PhD, MBA) preferred.
- 8+ years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a GMP environment.
- Experience in multiple disciplines within Quality Control desired: solid dosage formats, sterile injectables, small and large molecules, drug delivery devices and diagnostics.
- Must have in-depth knowledge of global regulations including FDA, EMA, MHRA and PMDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.
- Experience in evolving cGMP related quality systems, policies and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
- Well versed in analytical and characterization procedures for biopharmaceuticals and small molecules including HPLC, GC, MS, electrophoresis, immunoassays, bioburden, endotoxin, moisture, assay and dissolution testing.
- Experience desired with drug delivery devices, diagnostics, biomarker and genetic testing.
- Expertise in design of method validation, transfer and stability studies consistent with regulatory, quality and pharmaceutical best practices.
- Competent in the use of software applications, including iStability, LC chromatographic analyses, statistical applications and quality management systems (e.g. Master Control, Veeva).
- Participation in Quality Audits and selection of vendors
- Experience with managing external CMO and contract laboratory environments
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Possess strong customer service, conflict management and negotiation skills.
- Excellent verbal and written communication skills.
- Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of scientific quality and compliance.
- Travel estimated at 15-20%.
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org
Equal Opportunity Employer
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