Site Quality Head, East Norriton
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.
For more information, visit www.resilience.com.
Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We just started an incredible journey and are looking for passionate leaders to join us on this important mission.
The Site Quality Head is accountable for the quality oversight of the GMP operations at the manufacturing plant located in East Norriton, PA. The Site Quality Head is a key leadership role and reports to the Chief Quality Officer. The position will be onsite in East Norriton, PA.
Provides compliance and strategic guidance during the design and qualification of the plant expansions.
Accountable for recruiting talent and building a high performance Quality team. Mentors and develops personnel and ensures team’s agility, versatility and expertise redundancy.
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
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
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.
Accountable for product disposition to Clients. Assures timely notification, investigation and mitigation of quality events.
Accountable for timely notification and effective management of internal and Client-related changes
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.
Manages effectively the site’s GMP training program. Champions initiatives for continued learning and development.
Represents site Quality in corporate planning and joint Client-Resilience forums, as applicable
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.
Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals
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
Comprehensive knowledge of global GMP regulatory requirements for cell & gene therapy products
Hands-on experience with overseeing GMP operations at a cell or gene therapy manufacturing plant
Experience with managing regulatory agency inspections
Proven record with building high performance Quality teams
Excellent oral and written communication skills
Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
Demonstrated ability to successfully execute responsibilities in a fast-pace environment, collaborating across corporate functions and multiple stakeholders
Experience with facility commissioning and qualification
______________________________________________________________________________Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $225,000.00 - $281,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.