"Developing and Manufacturing your Cell Therapies from Benchtop to Bedside."
Job Summary
Cellipont Bioservices is growing, and we are looking for an Associate Director, Quality Assurance who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The Associate Director, Quality Assurance provides strategic oversight and leadership to QA Client liaisons and operations to ensure project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological products, and compliance to US and EU regulations, as applicable.
The Role
- Drives strategic projects within Quality as well as operational excellence and continuous improvement efforts
- Ensure that the phase-appropriate systems are implemented to ensure a consistent level of quality and compliance in all processes.
- Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements
- Establish and report on key performance indicators, including the use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation
- Directs the batch record review and lot disposition activities to ensure the release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
- Facilitates QA support and works closely with other Cellipont functional units including Manufacturing, Validation, Facilities Engineering, Pre-Clinical, and Quality Control to assess and resolve quality issues concerning the facility and products manufactured
- Develop and implement procedures, programs, and policies that support GMP operations and overall compliance strategy
- Serve as a team leader in quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
- System owner of Client Audit, CAPA and non-conformance management, Risk Management and Change Control programs
- Oversees QA Client liaison for hosting routine client audits. This includes coordinating audit support, performing facility tours, answering questions, and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated
- Participate in the Quality Metric review process, assess data for adverse trends, develop solutions, and oversee implementation
- Responsible for staffing and overseeing training, professional development of employees, and conducting performance reviews within the group
- Participate in facility expansion, coordinating QA support.
- Continuous reviews of all quality systems and procedures (SOPs) for efficiency and regulatory compliance improvements.
- Work with senior management on new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
- Partner with leadership and customers to drive strategic priorities with a large focus on present and future state organizational structuring and strategic planning based on growth models.
The Candidate
- B.S. in a Life Sciences discipline- OR - M.S. in a Life Sciences discipline
- 10+ years of relevant experience within the life sciences industry, preferably biotechnology or pharmaceuticals, performing within a Quality Assurance role
- 8+ years of direct management experience
- Thorough knowledge of cGMP regulations, quality systems, and regulatory requirements
- Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc)
- Advanced skills with MS Office applications and Adobe Acrobat
- Experience supporting Federal government contracts is a plus
- In-depth knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP, ICH Guidelines, and industry best practices. EU GMPs a plus.
- Knowledgeable and/or exposed to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish. Exposure to contract manufacturing is a plus.
- Ability to quickly learn new and novel manufacturing processes supporting new clients
- Ability to self-direct, and adapt to changing priorities
- Excellent communication and interpersonal skills required
- Strong attention to detail and organization skills required
- Proven technical writing and editing skills
- Creative individual with excellent problem-solving and troubleshooting skills
- Requires the ability to produce results in a fast-paced environment to meet client deadlines
- Established leadership capabilities
Position Benefits
- Opportunities for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross-functional exposure to other areas of within the organization
- Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
- 401K strong employer match
- Tuition Reimbursement
- Employee Referral Bonuses
- Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
- Gain experience in the cutting-edge cell therapy space
"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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