AlphaPro Technology, A.P.R., Inc. · 4 hours ago
Pharmaceutical Quality Assurance Manager
United States
Contract
Remote
Senior Level, Lead/Staff
8+ years exp
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Hiring Manager
Satya Singh
Insider Connection @AlphaPro Technology, A.P.R., Inc.
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Responsibilities
Oversee the drug substance (DS), drug product (DP), reference standard, and packaging/labeling/serialization contract service providers (CSPs) for clinical-phase and commercial production activities
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.)
Support stability program strategy including product shelf life and execution.
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints. Actively gathers necessary SME’s and leads team to resolve issues as applicable.
Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities
Support vendor qualification program, review written reports, follow up to resolve findings, and monitor CSP performance
Development, maintenance, and review of clinical and commercial Quality Agreements
Act as Product Quality Lead in CMC, Program, and CSP team meetings to provide strategic direction and leadership to product development, registration, and approvals.
Owns the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions are managed to conclusion.
Direct the disposition (release/reject) activities interfacing with a QP where applicable.
Ensure cohesive collaboration across CSPs for timely review of manufacturing records
Ensure robust processes are implemented for product management (e.g., control strategy, technology transfer, process validation lifecycle, quality monitoring).
Interface with Regulatory Affairs to review, and approve regulatory filings (IND, NDA)
Support pre-approval inspection and commercial readiness activities.
Participate in hosting regulatory inspections, support or perform internal and external audits.
Qualification
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Required
BA or BS degree in Chemistry or related field
8 + years in a GMP setting working with clinical and commercial products
Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
Proven track record and experience in supporting regulatory inspections (FDA, EMA)
Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products.
Experience with disposition of product batches and interfacing with a QP and CSPs
Excellent written, organizational and oral communication skills.
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all their forms.
Highly organized and detail-oriented with a passion to deliver quality results.
Ability to travel domestically and internationally to meet program needs (estimated 15-20%).
Preferred
Experience with product monitoring, complaint handling, issue resolution preferred
Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
Company
AlphaPro Technology, A.P.R., Inc.
AlphaProTemps is an award winning staffing services and consulting company with a tradition of excellence and a history of increasing client productivity and reducing costs.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
