Senior Manager, Quality Assurance Operations

Cellipont Bioservices • The Woodlands, TX

3d

About The Position

Cellipont Bioservices is growing, and we are looking for a Senior Manager, QA Operations who believes in the potential of bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level. The Senior Manager, QA Operations is responsible for overseeing and leading a multi-shift QA Operations function. QA Operations includes: clinical/commercial manufacturing and analytical support, batch record review and disposition, QA Floor support, assessing product quality related issues, and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of ATMPs. The Senior Manager, QA Operations plays a key role demonstrating the values, culture and deliverables for the site. This is an exciting opportunity to lead and drive a dynamic, multi-shift Quality Assurance Operations team. As the Senior Manager, you'll be at the heart of QA Operations-overseeing clinical and commercial manufacturing, providing analytical support, guiding batch record review and disposition, and delivering critical QA Floor support. Your leadership will be instrumental in assessing product quality issues and ensuring unwavering compliance with regulatory and industry standards for phase-appropriate GMP manufacturing of ATMPs. In this key role, you'll have the chance to champion the site's values and culture, making a tangible impact on its deliverables and overall success

Requirements

• Bachelors Degree in a Life Science discipline.
• 8 yrs.+ years' quality experience within pharmaceuticals, strong preference for biologics or advanced therapeutics in a quality role.
• 4+ yrs. of direct manager experience
• Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
• Hands-on experience with early, late, and commercial manufacturing process transfers/qualifications/validations.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.
• Must be available to work occasional weekend or holiday support as needed

Responsibilities

• Provides strategic and tactical oversight and leadership to QA operations to ensure project objectives are met to a high-quality standard and according to commitments
• Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews
• Directs the batch record review and lot disposition activities to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
• Facilitates QA support and works closely with other CPB functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured
• Serve as team leader in quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
• Member of the Quality management team, participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation related to area
• Develops and implements procedures, programs and policies that support GMP clinical and commercial operations and overall compliance strategy
• Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success
• Review and approve validations, qualifications, risk assessments, and testing methods, as needed.
• Participate in facility expansion, coordinating QA support.
• Strategy reviewer, from a Quality validation perspective, of quality system documents including but not limited to CAPA, change controls, investigations, and deviations
• Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.
• Work with Senior Leadership to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
• Ensure that Quality requirements are met and appropriately documented for the product lifecycle according to procedures and regulatory requirements.
• Actively participates in client and regulatory audits.
• Perform additional duties as assigned.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees