Quality Operations, CMC

Quality Operations, CMC

Opportunity

As a Sr. Specialist in Quality Operations, CMC, you will handle various operational tasks to ensure product quality and compliance in the manufacturing, testing, control, validation, and release of drug substances and drug products for both commercial and clinical use. This role serves as a quality authority for the organization's pipeline of neurological disease products, making strategic quality decisions throughout the product lifecycle. You will work closely with the CMC team on clinical-stage development, launch readiness, and commercial quality operations.

Responsibilities:

• Supervise contract service providers (CSPs) involved in drug substance (DS), drug product (DP), reference standards, and packaging/labeling/serialization for clinical and commercial production.
• Review and approve key documents such as specifications, batch records, and tech transfer/validation protocols.
• Support stability program strategies, including product shelf life and execution.
• Lead and approve change controls, deviations, temperature excursions, investigations, out-of-specifications (OOX), corrective and preventive actions (CAPA), and product quality complaints. Gather necessary subject matter experts (SMEs) and lead teams to resolve issues.
• Conduct risk assessments and implement quality and process controls to ensure proper oversight of production activities.
• Support vendor qualification programs, review reports, resolve findings, and monitor CSP performance.
• Develop, maintain, and review clinical and commercial Quality Agreements.
• Serve as the Product Quality Lead in CMC, program, and CSP team meetings, providing strategic direction and leadership for product development, registration, and approvals.
• Manage the Annual Product Review/Product Quality Review (APR/PQR), ensuring regulatory requirements are met and actions are completed.
• Oversee the disposition (release/reject) activities, interfacing with a Qualified Person (QP) where applicable.
• Ensure cohesive collaboration across CSPs for timely review of manufacturing records.
• Implement robust processes for product management, including control strategy, technology transfer, process validation lifecycle, and quality monitoring.
• Collaborate with Regulatory Affairs to review and approve regulatory filings (IND, NDA).
• Support pre-approval inspections and commercial readiness activities.
• Participate in hosting regulatory inspections and conduct or support internal and external audits.

Qualifications:

• Bachelor's degree (BA or BS) in Chemistry or a related field.
• 5-7 years of experience in a GMP setting with clinical and commercial products.
• Hands-on experience in interpreting and implementing regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
• Proven track record in supporting regulatory inspections (FDA, EMA).
• Strong knowledge of quality management systems, quality control, development processes, and regulatory strategies for small molecule drug substances and solid oral drug products.
• Experience with product batch disposition and interfacing with a QP and CSPs.
• Excellent written, organizational, and oral communication skills.
• Ability to thrive in a fast-paced, innovative environment, remaining flexible, proactive, resourceful, and efficient.
• Experience in product monitoring, complaint handling, and issue resolution is preferred.
• High level of intellectual curiosity, innovation, and creative problem-solving with an entrepreneurial mindset; ability to thrive in an agile environment.
• Excellent interpersonal and communication skills, with the ability to build important relationships that foster trust and encourage diversity.
• Highly organized and detail-oriented with a strong commitment to delivering quality results.
• Willingness to travel domestically and internationally to meet program needs (estimated 15-20%).
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.