Manager of Quality Assurance/Quality Control
Provide quality leadership and expertise to internal/external partners, related activities to ensure that product is developed, manufactured, and released to meet cGMP requirements. Provide Quality oversight for developing, trouble-shooting, qualifying, validating and method transfer of analytical methods. Ensure continued Quality Compliance to meet U.S. FDA current Good Manufacturing Practices (cGMP), International Conference on Harmonization (ICH) and applicable ex-US regulations.
Manage ICH compliant stability programs including stability SOP, protocols, data analysis, trending and final reports. Report stability data for any internal and/or external filings, including those to government contracts and regulatory filings/updates.
Manage product specification, critical reagents and reference standard program to ensure quality and purity for scientifically valid results according to regulatory guidance. Manage SOPs, protocols, data analysis, trending, final reports and qualification certificates.
Create or manage documentation (SOPs, specifications, etc) to address current and future Compliance needs. Perform assessments for Compliance at third party subcontractors.
Quality analytical data review and managing investigations at subcontractor locations.
Stability, Reference Standard and Specification Programs.
Function as a SME for quality system audits, as needed.
Manage execution of stability studies, trending and reporting.
Manage reference standard program; provide oversight for execution, qualification and requalification of reference standards.
Provide quality oversight and regulatory Compliance input into the development, optimization, qualification, transfer and validation of analytical methods.
Ensure Compliance is maintained in audit readiness for hosting government contractor’s and/or FDA audits. Prepare, organize and edit, as required, quality related responses to questions/issues derived from audits or from quality related regulatory submissions.
Maintain working knowledge of SOPs, relevant GxP regulations and ICH guidelines.
Provide quality/technical expertise and oversight, where necessary.
Other duties, as assigned.
Broad knowledge of the drug development process, ICH, GxP guidelines, and applicable regulations is essential. High degree of understanding and ability to apply knowledge of regulatory requirements.
Experience supporting Compliance in development and manufacturing operations, including creating SOPs, reviewing critical documents, auditing, etc. Experience in preparing and submitting reports to and interacting with the government agencies.
Successfully developed, transferred, validated or verified compendial methods, physico-chemical assays, bioassays and cell-based assays.
Successful experience in managing work processes and Compliance at subcontractor locations, including providing quality oversight for method transfer, qualifications, validations and guiding investigations.
Reliable and self-motivated with attention to detail. Competent with strong problem solving and negotiation skills.
Ability to independently develop and direct a project management program with viable contingency plans. Ability to interact professionally at multiple levels within an organization.
Flexibility and ability to adjust to quickly changing priorities and unforeseen events; excellent time management skills.
Ability to diplomatically manage highly sensitive information confidentially and professionally.
Education and Training/Certification
BS (Chemistry, Biology or other related Life Science)
High degree of understanding and ability to apply knowledge of regulatory requirements
Strong knowledge of compendial methods, physic-chemical, bioassays and cell-based assays development, qualification, validation, and verification for biological products
Experience in analytical chemistry, biological methods and stability
Experience in biologics/vaccines
Comfortable with statistical methods for data analysis and trending
Related Work Experience:
5-10 years experience managing QA/QC operations and GMP Compliance in the Biotechnology or Pharmaceutical industry. Experience in Quality Control is preferred.
8+ years experience in quality oversight for method development, qualification and validation
Must have 8+ years experience with biologics, preferably vaccines.
Experience with both commercial and investigation products a plus
Proficiency in Compliance disciplines, i.e., GxPs, ICH
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