Quality Operations Manager, CMC
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Quality Operations Manager overseeing drug product compliance and quality operations. Working with CMC team supporting clinical trials and commercial readiness activities.
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, gathering necessary SMEs to resolve issues as applicable.
- Perform risk assessment and implement appropriate quality and process controls for production activities.
- Support vendor qualification program, review written reports, follow up to resolve findings, and monitor CSP performance.
- Develop, maintain, and review 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.
- Own the APR/PQR, coordinating to ensure regulatory requirements are met and actions 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.
Requirements:
- BA or BS degree in Chemistry or related field.
- 5+ years in a GMP setting working with clinical and commercial products.
- Firsthand experience with 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, 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.
- 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.
- Excellent interpersonal 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%).
Benefits:
- 99% premium paid for medical, dental, and vision plans.
- Company-paid life insurance, AD&D, and disability benefits.
- Voluntary plans to personalize coverage.
- Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays, and company-wide shutdowns.
Similar Jobs
Drivers Operations Executive
Drivers Operation Executive supporting efficient operations and responses for drivers. Ensuring exceptional delivery service and managing key performance indicators at Justo in Chile.
Driver Operations Executive
Drivers Operation Executive at Justo, supporting delivery operations and improving efficiency in Colombia. Ensuring exceptional service while minimizing operational costs with a remote working setup.
VP Franchise Operations – Owner Relations, Americas Classics & Luxury Portfolio
VP of Franchise Operations overseeing financial performance and brand standards for Hyatt's Classics & Luxury portfolio. Leading a team to maximize brand value with owners and operators.
Program Lead – ROPS
Program Lead coordinating logistics and improvement of high complexity learning programs for DaVita's leadership development. Responsible for planning, execution, and analysis of curriculum effectiveness.
Director, Services Operations – Planning
Director of Client Operations & Planning driving operational clarity for a trusted commerce network. Collaborating with executive leadership on strategic priorities and operational outcomes.
IT Operations Analyst
Incident Management Analyst driving efficiency in incident management processes in a technology support environment. Managing incidents through proactive analysis and facilitating resolution across teams.
Senior Director of Operations
Senior Director of Operations leading and scaling operational strategies for Single Event department. Driving performance and efficiency for lien resolution offerings and team leadership.
Operations Supervisor
Operations Supervisor managing product launch processes at Hadley Designs, ensuring on-time and high-quality execution in a fast-paced environment.
Marketplace Operations Associate
Marketplace Operations Associate focused on building and running clinician scheduling operations for Wheel Medical Groups. Leveraging AI and data to enhance operational performance and clinician engagement.
Director, Solutions Strategy – Operations
Director of Solutions Strategy & Operations responsible for operational foundations in fast-growing functions. Building systems for technical teams with a focus on scalable solutions.
Product/Process Engineer, Broadband Operations
Product/Process Engineer leading the manufacturing lifecycle of optoelectronic products at Ciena. Ensuring production readiness, reliability, and performance for high-performance networks globally.
Associate, Market Operations
Associate, Market Operations ensuring integrity of DraftKings’ prediction markets. Manage market activities, provide operational support, and conduct surveillance in a dynamic regulatory context.
Senior Manager – Testing Operations
Sr. Manager Testing Operations at Luminare Health managing testing strategy and planning meetings. Leads testing programs ensuring business outcomes by developing consultative teams and engaging methodologies.
Community Operations Intern
Intern role in community operations directly engaging users through various interactions. Focusing on user behavior understanding and relationship building for growth opportunities.
Client Operations Associate
Remote Client Operations Associate role at Blyss Journeys, responsible for client requests and documentation in a flexible scheduling environment.
Lead, Executive Operations
Lead, Executive Operations to structure execution for CEO and leadership team. Collaborate with teams to translate priorities into actionable plans for improved clarity.
Lead, Executive Operations
Lead, Executive Operations focusing on building simple structures for the CEO and leadership team. Coordinating across functions to improve clarity and reduce friction in high-priority work.
Operations Executive – Junior Production Coordinator, 1–3 Years Experience
Operations Executive supporting residential interior fit-out projects and coordinating with internal teams for smooth execution. Ensuring positive customer experience and adherence to design standards.
Senior Operations Analyst
Senior Operations Analyst at Argano overseeing project data and delivery processes. Driving operational excellence and strategic initiatives with cross-functional collaboration and mentorship.
Lead IT Operations Engineer
Lead IT Operations Engineer managing cloud IT infrastructure and operations, focusing on Microsoft 365 and Azure configurations while ensuring security and efficiency.