Advanced Clinical · 3 hours ago
Director of Quality Assurance (GMP / CMC)
United States
Full-time
Remote
Director/Executive
$160K/yr - $180K/yr
10+ years exp
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Responsibilities
Help the Quality organization to lead, hold accountability, and provide overall quality oversight of internal processes and procedures as well as work closely with contract manufacturing, contract laboratories, clinical research organizations, raw material, and service providers as well as internal departments of R&D, Process Sciences and Manufacturing
Collaborate with senior leadership to provide strategic and technical guidance of Quality Assurance activities and outcomes.
Responsible for fulfilling managerial responsibilities in accordance with the Direct Biologics policies, procedures and state, federal and local laws
Lead with a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors
Provide strong strategic leadership for QA in support of Good Manufacturing Practices (GMPs)
Help implement, monitor, and promote good practice of all Quality Assurance Systems to ensure compliance with relevant FDA, EMA/other regulations/directives/requirements and ICH guidelines
Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs.
Develop and implement a common platform of quality and compliance systems, tools, procedures, and standards company-wide
Evolve, audit, and monitor Standard Operating Procedures (SOPs) to ensure they are in accordance with GMP guidelines. Carry out corrective actions for identified deviations
Design, develop, and review QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards across R&D, CMC, Process Sciences and Clinical Affairs
Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s, CMOs, CROs, and Packaging Facilities
Ensure completeness of technical evaluation and quality due diligence activities in support of CDMO/CRO site selection process
Provide stewardship of the quality risk profile and team risk log and approve risk controls strategies at CDMOs/CROs both in the selection and manage phases.
Review Quality Agreements, Master Service Agreement and protocols for CDMOs and CROs to implement in order to ensure requirements for regulatory filing
Drive process and product quality through effective CMC quality systems, ensuring adequate supplier oversight/surveillance
Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling and Packaging
Ensure that all necessary steps are added to the Process Control Strategy
Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
Ensure that all products manufactured meet the registration and cGMP requirements based on FDA /global regulatory requirements.
Ensure that DB and our partners are inspection-ready for health authority audits by regulatory agencies; lead engagements with health authorities
Accountable for training and education on GxPs and SOPs and eQMS systems company-wide
Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures. Strategize responses to regulatory questions during review period and product lifecycle.
Provide oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections
Continuous improvement with Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), EU, and other pertinent compliance organizations and regulations
Qualification
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Required
Bachelor’s Degree in a scientific discipline required
10 years of pharmaceutical Quality Assurance, Regulatory Affairs, Manufacturing; or an equivalent combination of education and/or experience
Experience with GMP requirements and with US and International regulatory authority inspection requirements
Experience with successful collaborations on IND, BLA/NDA, and MAA submissions for novel products
Experience with early/mid/late-stage development and marketed products
Relevant knowledge and experience base working with R&D and manufacturing groups on quality issues is required.
Experience based on global GMP and QA issues pertaining to biologics/vaccines or regenerative medicine therapies is required.
In-depth knowledge of FDA, EU and International regulations, EU, and US compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications, and cGMP.
Demonstrate quality mindset and influences across the entire organization.
Proficient in risk assessment and root cause analysis tools.
Preferred
Advanced degree preferred (MS/PhD/PharmD)
Company
Advanced Clinical
Advanced Clinical is a pharmaceuticals company offering CRO, FSP, quality, and validation services.
1,001-5,000 employees
H1B Sponsorship
Advanced Clinical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (2)
2021 (6)
2020 (7)
Funding
Current Stage
Late StageLeadership Team
Julie Ross
President & CEO
Kasey Dudley, SPHR, GPHR, PHR
Manager, People and Culture Business Partner
Recent News
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