Director/Sr. Dir. QC
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Director/Sr. Director, QC to work for a leading San Diego biotechnology company.
Director/Sr. Director, Quality Control
This position will be responsible for providing strategic direction and management of Quality Control (QC), Commercial and Developmental Stability (Stability) group activities including QC testing at contract testing labs and contract drug substance and drug product manufacturing operations. This individual will work closely with Pharmaceutical Sciences, Technical Operations, and Quality Assurance to manage the method transfers, methods validation, data oversight and ensure timelines coincide with process development and production schedules. This includes vendor oversight, data review, external auditing, exceptions management (Deviations, CAPAs), and change control as it relates to GMP quality testing. This position will oversee designation of critical quality attributes, trending of method performance as well as in process, release and stability data, and setting of specification. This position directs method transfers and method validation and is knowledgeable regarding corporate quality systems for laboratory controls. This position requires up to 25% USA and international travel.
- Ensures contracted third-party testing (CMOs and Labs) are in compliance with appropriate quality practices to meet the desired quality attributes of the Company and ensures the facilities/quality systems will pass regulatory inspections.
- Oversees method transfers and method validations at contract labs and CMOs.
- Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
- Reviews QC raw data from third parties, and generates Certificates of Analysis.
- Contributes to appropriate sections of Annual Product Reviews for applicable products.
- Authors QC-related sections (e.g., batch analysis, analytical methods, reference standard, specification) of regulatory filings.
- Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.
- Participates in cGMP audits of contract testing labs.
- Supports corporate and third party inspection readiness activities.
- Serves as an SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections.
- Understands and proposes improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
- BS in the Sciences and 15 years (or combination of MS with 12 years, PhD with 10 years) of experience in pharmaceutical QC operations for development through commercial products; parenteral experience required, medical device experience a plus.
- Has experience working in a development, GMP and GLP environment as it applies to laboratory and stability functions and has experience in preparing and complying with required regulatory guidelines involving PAI and Inspection planning and follow-up.
- Experienced in analytical methods development and validation, method transfer activities, and continuous improvement. This will involve oversight of GMP, GLP, GCP and Medical Device testing at CROs, CRLs and CMOs as it applies to laboratory and stability functions.
- Demonstrated ability to work in multi-disciplinary settings acting as facilitator and coach.
- Strong leadership, team building, organizational, communication and interpersonal skills.
- Has experience in overseeing and planning budgets and monitoring expenses. Provides direction on Goals and Objectives to support company strategic direction.
- Position requires up to 25% USA and international travel.