Description
The Associate Director of GMP Quality Assurance leads the GMP QA strategy and execution of Catalyst’s commercial product portfolio. Acting as the QA subject matter expert, this role supports CMC activities, including creating master specifications, batch review, product release, stability programs, change control, and vendor management for three product lines.
Requirements
Responsibilities (including but not limited to):
- Ensures compliance with cGMP standards, oversees QA activities at CDMOs, performs critical documentation reviews, and develops/evolves ‘fit-for-purpose’ SOPs aligned with the QMS
- Maintains and manages an innovative and risk-based model for vendor quality oversight, vendor performance and ensure timely resolution of quality issues
- Maintains up-to-date integrated quality KPIs and risk scorecards across CDMOs
- Partners with various cross-functional teams and business stakeholders (such as Regulatory, Drug Safety, Supply Chain, Finance, Medical Affairs, and Commercial teams) to ensure adequate quality processes, governance, and quality oversight for all Catalyst commercial product lines
- Provides leadership and manages staff including participation in company performance management and development processes
- Ensures that our internal processes are fit for purpose, maintain compliance, and inspection ready
- Works effectively with CDMOs to resolve complex quality issues with Catalyst product, maintaining GMP compliance and patient safety as the highest priority
- Engages cross-functionally, including the Legal and Compliance team in negotiations when necessary
- Works with the VP Quality Assurance and R&D Compliance to create and build a scalable GMP product quality system for an expanding Catalyst portfolio
- Represents Commercial QA in new product onboarding projects
- Identifies quality improvements within Catalyst quality systems to maintain compliance and improve efficiency utilizing risk-based methodologies, as related to vendor management/vendor oversight
- Implement and maintain a GxP compliant Quality Management System (QMS) by facilitating and/or supporting related tasks
- Monitor and partner with vendors to ensure that Catalyst products are manufactured, stored and distributed in compliance with GxP requirements, Including:
Provide GMP QA leadership and support CMC, API, drug product, and supply chain/logistics operations related to all GMP contract manufacturing organizations utilized by Catalyst, including US DSCSA Serialization requirements
- Ensure all API, drug product and investigational product batches are released on time
- Review and approve of Master Batch Records and executed batched records
- Work with Contract Manufacturing Organizations to resolve and approve deviations, out of specifications, or any compliance issues
- Review and approve label proofs
- Review and approve Method Validations, Method Transfers, Material Specifications, Stability Data, and Cleaning Validations
- Initiate and follow up on Change Controls, Deviations, and CAPAs
- Review and approved APRs
- Oversee Catalyst product stability and complaint programs
- Responsible for mock recall program
- Ensure that Quality Standard Operating Procedures (SOPs) are implemented in accordance with US (21 CFR 210 & 211) and other cGMP/GDP guidelines as applicable
- In collaboration with Senior Management, weigh and communicate quality and compliance risks as appropriate?
Education/Experience/Skills
- Bachelor's Degree in life science or pharmacy required; Advanced degree a plus
- Professional certifications, such as Six sigma, ASQ CQA, etc. a plus
- Significant experience with quality assurance, quality control, manufacturing, combination product/medical device production, or other relevant experience typically gained within a minimum of 15 years of experience
- Small molecule experience (Biologics is a plus) in a virtual manufacturing environment or CMO QA Vendor Management role
- Demonstrated working knowledge and experience applying Quality regulations and standards (GMP 210, 211, 820; ISO13485, etc.)
- Global travel up to 25% of time may be required
Skills Required
- Strong leadership and organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment. Experience working independently
- Able to work with the following programs on an intermediate level: Veeva, Adobe Acrobat, MS Word, Excel, Smartsheets, and Outlook
- Excellent attention to detail and ability to multi-task in a fast-paced hyper-growth environment
- Strong written and verbal communication skills
- Ability to influence senior management, peers and other colleagues without direct reporting lines
- Be able to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
- ISO Certified Lead Auditor-preferred
- Knowledge of US DCSCA requirements and implementation-preferred
Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here: https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true
The base salary for this position will range from $160,000 to $185,000. Candidate experience, professional licensing, and geographic location will be taken into consideration.
Employment is contingent upon successful completion of all required screening and verification processes, including for authority to work in the United States.
EEO Statement
Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies
Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.
