Synedgen is seeking a talented Manager of Quality Assurance with expertise in CMC and early stage (pre-IND and early clinical) compliance with a minimum 5 years’ experience working in Quality Assurance in a Pharmaceutical FDA regulated industry. The Quality Manager must be adept at working both independently and collaboratively with other business verticals, including manufacturing, QC, CMC regulatory, Contract Research Organizations and management. The ideal candidate will have experience in Quality System Development, CMC conformance, Gap analysis and Remediation, together with a solid knowledge of relevant regulatory agency guidance including ICH and FDA. The QA Manger is responsible for overall management of Quality Assurance operations and assures all applicable regulations are followed.
Roles & Responsibilities
- Author and review procedures, specifications, quality reports, and other quality documents, customized to different client business processes and requirements.
- Participate or lead as appropriate meeting with QA, QC and manufacturing teams and reporting to management.
- Provide QA support and assistance for facilities, utilities, and equipment; review and disposition Out-of-Tolerance records for equipment; review technical, investigation, validation/ qualification documentation related to Production with appropriate audit trail.
- Manage data integrity practices/ requirements in Production as established by Synedgen Policies, site procedures and regulations.
- Oversee timely initiation of deviations and investigations related to Production; assure investigations are completed in satisfactory manner and in accordance with the level/ classification of discrepancy.
- Lead initiation, evaluation and completion of Change Controls related to Production.
- Propose Corrective and Preventive Actions for continuous improvement of system and activities in Production; ensure all associated CAPAs are implemented according to the established procedures and policies.
- Provide information for Product Quality Reviews and participate in review/approval of PQRs.
- Participate in and support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
- Support Management during regulatory agency inspections and audits
- Work collaboratively to optimize appropriate Quality systems for Synedgen’s pre-clinical programs and to and implement phase appropriate systems.
- Act as a subject matter expert on quality issues and compliance-related matters for manufacturing, packaging and distribution to CRO’s.
- Conduct Quality audits for incoming materials and CRO’s.
- Achieve and maintain appropriate gowning requirements to provide QA on-the-floor oversight, line clearance and other QA functions in Production area.
- Ensure process control measures are in place and followed in product manufacturing.
- Perform QA review and approval of Master Batch Records, forms, procedures, test methods and other master documents related to Production.
- Manage and ensure that deviations, discrepancies, change controls, etc. related to Production are resolved and closed prior to batch release.
- Direct timely issuance of production records, procedures and other documentation.
Qualifications & Education Requirements
- BS/MS in the life sciences or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.
- 5+ years of experience in CMC Quality Assurance in the pharma or biotech industry.
- 3 + years of personnel supervisor / manager experience.
- Understanding of Quality system reviews, deviations, OOS, CAPAs, and other remediation plans
- Comprehensive understanding of CFR regulations (21CFR Part 210, 211 etc), ICH guidelines, quality management systems initiatives, and standards.
- Working knowledge and ability to apply GMPs in conformance to U.S. standards and exposure to CMC/Pharma Development and development teams.
- Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
- Experience performing GMP audits of manufacturing facilities of vendors and internal operations.
- Understanding of computer systems validation methodologies and related industry expectations.
Required Personal Skills
- Enthusiasm to help build the assets of a small, growing pharmaceutical company
- Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Proficient in MS Word, Excel, Power Point and other applications. Familiarity with electronic systems for Batch Record, Quality Management Systems, is a plus.
- Excellent team-building, leadership, and management skills.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Strong problem solving/process improvement skills with ability to both be a part of and own solutions.
- Adept at applying risk-based and phase-appropriate quality approaches.
- Strong attention to detail and the ability to independently prioritize and multitask.
Applicants should provide a resume, a cover letter and 3 references. Applications without a cover letter will not be considered.
This position is full-time at the facility and is not eligible for remote work. Modest relocation expenses will be considered for exceptional candidates.
Synedgen is an equal opportunity employer. All qualified applicants will receive consideration for employment and advancement without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.