Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

QUALIFICATIONS AND KEY SUCCESS FACTORS

• 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.
• 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.
• 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%).
  The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• 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.