Director, Quality Assurance Operations
Apply NowCompany: Cellectis
Location: Raleigh, NC 27610
Description:
Job Description
POSITION RESPONSIBILITIES
EDUCATION AND EXPERIENCE
TECHNICAL SKILLS / CORE COMPETENCIES
POSITION RESPONSIBILITIES
- Ensure all aspects of the Quality system through direct observations and audits, identify and remediate all observations through robust CAPA and determines efficacy of these actions through effectiveness checks.
- Build out the Quality function in accordance with ICH, FDA, and EMA guidelines, providing strategic phase appropriate direction for quality initiatives while remaining hands-on.
- Develops cooperative and strong working relationships with Manufacturing, Quality Control, Analytical Development, Process Development, and MSAT to achieve company objectives
- Participates in business sub-teams as a Subject Matter Expert (SME) to provide input on timeliness and compliance related issues
- Develops functional capabilities within the department to keep pace with advances in technology and company growth
- Provides oversight and leadership to the Quality Organization to foster a culture that encourages independent thinking and personnel who excel at building strong relationships across multiple functions both locally and globally
- Ensures and promotes compliance with applicable US and European cGMP regulations, corporate policies and company Standard Operating Procedures
- Provides input based on knowledge and experience on QA Operations, procedures and cGMP issues
- Provides Quality Assurance related support to all GMP departments
- Ensures timely issuance, review and approval of QA certificates, closure of Batch Records, deviation reports etc.
- Evaluates and approves deviation reports and initiates and coordinate corrective and preventive actions as required
- Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies
- Develops quality strategies and priorities for short- and long-term objectives for the QA organization.
- Develop KPIs to track and trend key Quality Indicators and ensures that any adverse trends or patterns are noted and are promptly addressed
- Travel up to 5% of the time
- Such other responsibilities and duties as the Company may from time-to-time assign
EDUCATION AND EXPERIENCE
- Bachelor's or master's degree in science preferably in a Life Science, with at least twelve (12) years of relevant QA experience in a biopharmaceutical company.
- 8+ years of direct supervisory experience.
- Experience writing Standard Operating Procedures and Work Instructions.
TECHNICAL SKILLS / CORE COMPETENCIES
- Comprehensive knowledge of cell and gene therapy, manufacturing operations, GMPS, and the theories and general principles behind them.
- Comprehensive knowledge of compliance with cGMP regulations.
- Strong project management skills.
- Working knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity.
- Knowledge and understanding of regulations regarding cell/gene manufacturing including but not limited to cGMP as defined by the US Food and Drug Administration and European Medicines Agency.
- Understanding of aseptic manufacturing.
- Strong written and verbal communication skills.
- Accountable for making independent decisions regarding daily QA Operations.
- Ability to set and manage priorities and schedule activities accordingly.
- Strong analytical and problem solving skills.
- Demonstrated interpersonal skills to work effectively with subordinates, peers, managers, and cross-functional teams.
- Excellent organizational skills with attention to detail and deadlines.
- Strong team orientation including the ability to coach and mentor.