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Site Quality Head, East Norriton
Company | BioSpace |
Address | East Norriton, PA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-07-25 |
Posted at | 10 months ago |
Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.
- Accountable for recruiting talent and building a high performance Quality team. Mentors and develops personnel and ensures team’s agility, versatility and expertise redundancy.
- Provides compliance and strategic guidance during the design and qualification of the plant expansions.
- Manages effectively the site’s GMP training program. Champions initiatives for continued learning and development.
- Prepares and hosts periodic site Quality Management Reviews to assess the health of the Quality Systems; identifies unfavorable trends and collaborates with stakeholders to ensure their timely mitigation. Contributes to the periodic corporate Quality Management Review and ensures a harmonized implementation of risk mitigation initiatives.
- Oversees and/or contributes to the development and execution of Quality Agreements with Clients. Accountable for the timely and compliant delivery of site’s responsibilities in accordance with the Quality Agreement requirements.
- Leads site audit and regulatory inspection readiness plan. Leads and hosts Client audits and regulatory inspections. Ensures timely and compliant responses and resolution of identified deficiencies.
- Accountable for timely notification and effective management of internal and Client-related changes
- Accountable for developing site processes and procedures in order to successfully fulfill the responsibilities for Quality Systems and Compliance, Quality Assurance, Quality Engineering and Quality Control
- Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals
- Oversees the GMP operations at the East Norriton manufacturing plant and ensures adherence to corporate policies/standards and applicable GMP regulations
- Collaborates with other Quality leaders and stakeholders and assists in the implementation, continuous improvement and lifecycle management of implemented GMP policies and quality management system
- Represents site Quality in corporate planning and joint Client-Resilience forums, as applicable
- Accountable for product disposition to Clients. Assures timely notification, investigation and mitigation of quality events.
- Demonstrated ability to successfully execute responsibilities in a fast-pace environment, collaborating across corporate functions and multiple stakeholders
- Excellent oral and written communication skills
- Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field
- Pharmaceutical and/or Biotechnology industry experience, with 5-7 years of experience in a senior quality organizational leadership role
- Proven record with building high performance Quality teams
- Hands-on experience with overseeing GMP operations at a cell or gene therapy manufacturing plant
- Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
- Comprehensive knowledge of global GMP regulatory requirements for cell & gene therapy products
- Experience with managing regulatory agency inspections
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
- Experience with facility commissioning and qualification
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