Quality Compliance Associate Director - Remote - 15718
Remote, MA 02210 US
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Title: Quality Compliance Associate Director
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Temp
- Pay rate: $105-115/hr
- Job Location: Remote
- Job#: bh14586
Quality Compliance Associate Director
The Quality Compliance Associate Director provides technical and strategic leadership for quality systems, inspection readiness, risk management, and quality culture for the cell and gene therapy business unit. This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance.
- Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
- Leads and manages complex projects/teams within corporate objectives and project timelines
- Provide technical and strategic support to functional areas including other quality groups for change controls, deviations, qualification, and risk assessments
- Participates in cross-functional projects in Quality expert and leader role
- Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
- Identifies and facilitates resolution of technical issues in partnership with QA Operations.
- Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
- Provides tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
- Supports inspection readiness by providing strategic and technical guidance and coaching to both internal and external personnel
- Provides support for QA Talent Strategy, in alignment with overall QA Mission and Strategy and corporate HR processes
- Facilitates design, execution, monitoring and maintenance of QA Resource Management process and tools to support appropriate allocation of people resources.
• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically 8+ yrs experience
• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: Aseptic practices, auditing techniques, facility design, and QMS design
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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