Senior Manager, Quality Control

The Role:
Reporting to the Associate Director, Analytical Sciences /QC, the Senior Manager, Quality Control will lead the Quality Control activities for a late-stage small molecule oncology program in the Analytical Sciences team. The successful candidate needs to demonstrate a proven track record of working with CROs/CMOs to support the in-process, release and stability testing of regulatory starting material, intermediates, drug substance, and drug product, as well as the review of manufacturing and distribution documents for clinical and marketed product. 

The ability to thrive in a virtual environment in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced clinical development programs, and to coordinate commercial readiness deliverables will be critical. As the Quality Control expert, the candidate is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality Control department performs to a standard that ensures the quality of products and materials produced by our contracted partners.  

The candidate will interface with the program’s Analytical, Drug Substance, Drug Product, Quality Assurance, and Regulatory CMC functional representatives. Responsibilities include ensuring that drug substance and drug product QC support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team. 

Responsibilities:

•    Work with internal teams, CMOs, and Test Labs to assemble data packages in support of shelf-life extension's, specification and method changes, associated batch records, related data, and program life cycles.
•    Cross functional contribution to derive and implement the best QC practice for a late phase program.
•    QC review of analytical release and stability data for completeness, accuracy, consistency with specification's and/or protocol design as applicable.
•    QC review of method development, method validation, method transfer, and regulatory source documents.
•    Tabulate, assessment, and archival of stability testing data as part of product and method life cycle management. Identify trends and ensure data is analyzed to help understand degradation pathways in aid of product life cycle.
•    Investigate and resolve analytical test failures (OOS and atypical results) with support of cross-functional team.
•    Collaborate closely with the functional teams to support the synthesis, certification, release, and management of associated reference material. 
•    Author and/or review QC sections (e.g., batch analysis, analytical methods, reference standard, etc) of regulatory submission documents, as well as author and review relevant change controls and SOPs. 
•    Contribute to appropriate sections of CMC sections for submission as well as Annual Product Reviews. 
•    Participate in vendor and internal audits as needed. 

Competencies Include:
•    Excellent organization and multi-tasking skills and ability to drive and deliver multiple projects within project scope and timelines.
•    Ability to think critically with strong attention to detail.
•    Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
•    Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.

Qualifications: 
•    BS or equivalent in chemistry or related discipline with a minimum of eight (8) years of relevant industry experience (or MS/PhD with 5+ years’ experience) with at least 2 of those years at the QC Manager lev-el.
•    A strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines with the ability to apply them to analytical drug substance and drug product development and manufacturing is required.
•    Knowledge of analytical testing concepts in small-molecule Drug Substance and Drug Product including laboratory controls and good documentation practices.  
•    Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections.
•    Ability to work with all levels of organization and external contract service providers to ensure compli-ance with current regulations.
•    Good understanding of product process and development, from discovery to commercialization
•    Knowledgeable in CGMP regulations and ICH or other industry guidance.
•    Proven track record solving analytical and QC challenges with a focus on small molecules.
•    Proficiency with JMP and application of statistical analysis concepts is preferred.