Senior Manager, Quality Assurance

Spyglass Pharma•Irvine, CA

2d•$160,000 - $180,000

About The Position

The Senior Manager of Quality Assurance role involves support for the Research & Development (R&D) and Operations teams, ensuring that all processes meet regulatory requirements and company Quality Management System. This position reports to the Senior Director, Quality with direct oversight of one other QA team member currently. Thie position will also play a key role that supports clinical and manufacturing operations. The Senior Manager ensures compliance with cGMP, GCP and GLP requirements through direct oversight of QA process including document control, supplier qualification, deviations/CAPA and batch disposition, and serves as a trusted cross-functional partner as the company advances from clinical development toward commercialization.

Requirements

B.S. in Chemistry, Biology, Engineering or related science.
10+ years of relevant experience in pharmaceutical industry with at least 5 years with direct quality assurance experience (additional medical device experience a plus)
3+ years of people management or team leadership experience (direct reports preferred), with demonstrated ability to coach, develop, and manage QA professionals
In-depth understanding of QA methodologies and process to support early phase development into late stage and commercial manufacturing.
Experience in clinical phases of development (ie. Phase 2 through Phase 3)
Knowledge of applicable FDA regulations (cGMP/GLP/GCP/QMSR/ISO) and ICH guidelines
Experience with combination products (drug/device) and 21 CFR Part 4 preferred.
Experience hosting or supporting regulatory inspections (FDA or other health authorities).
Excellent analytical and problem-solving skills to identify and resolve issues efficiently.
Experience in engaging vendors and CMOs
Experience in performing raw material and supplier qualification audits
Ability to influence cross-functional stakeholders and make sound, risk-based quality decisions.
Strong attention to detail, with the judgment to prioritize and delegate effectively.
Strong verbal skills, technical writing skills and ability to work with others in a collaborative manner.
Mentoring and training QA team members to enhance their skills and performance.

Nice To Haves

ASQ Certification (CQE, CQA) a strong plus

Responsibilities

Provide direct leadership, coaching, and performance management for the Quality Assurance Engineer; setting team priorities, workload, and individual development plans; delegate and review work to build team capability and bench strength.
Maintain QMS compliance with both drug regulations (21 CFR Part 210/211) and medical device requirements (21 CFR Part 820 / ISO 13485), specifically addressing 21 CFR Part 4 for combination products.
Responsible for managing GxP quality requirements supporting product development, phase appropriate and lifecycle management of clinical products, and the commercialization and launch.
Provide Quality oversight to ensure clinical and commercial product is manufactured, tested, stored, and distributed according to cGMP’s and other applicable regulations.
Ensure QA review and approval of records, and personally perform and provide key QA duties/support to CMC/Device development and operations teams during product development, clinical and commercial manufacturing including: Review and approve Master Production Records from Contract Manufacturing Organizations to include Drug Substance manufacturing, Drug Product manufacturing, Finished Drug Product labeling and packaging operations, and external laboratory oversight.
Reviews and approves executed records, certificates of analysis, client notifications, specifications, qualifications, investigations, deviations, CAPA, certificate of conformance
Perform product release for clinical investigational and commercial distribution
Raw Material Qualification
Review and approve validation protocols and validation reports as required.
Provide Quality assessments and approvals for internal and external Change Controls impacting clinical or commercial products
Serve as designated representative with critical CMO’s and work with technical operations to address manufacturing issues at the CMO.
Own the QA SOPs and work instruction lifecycle, authoring and delegating new documents and revisions to support quality functional activities.
Support Management review process through preparation of data and meeting minutes
Lead QA initiatives/projects for quality and continuous improvements
Understand and interpret regulatory policies and guidance as it pertains to GMP requirements and ensures compliance
Support regulatory agency inspection readiness activities, including mock inspections, gap assessments, and agency response coordination.
Collaborate with Regulatory Affairs, Clinical Operations, Medical Affairs, Manufacturing and R&D
Other duties as assigned.