Site Quality Head - Allston

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

The Site Quality Head ensures appropriate focus on Quality in all areas and activities of the cGMP operations at Resilience's manufacturing plant located in Boston, MA. The Site Quality Head is a key member of the site leadership team, reporting to the Chief Quality Officer, with responsibility for the analysis of Resilience quality requirements and the establishment, implementation and control of quality assurance systems and procedures across multiple disciplines.

This is an onsite position (Allston, MA); relocation assistance may be provided.

Position Responsibilities:

• Lead the site Quality organization in establishing systems and procedures necessary to ensure cGMP compliance.
• Develop site processes and procedures to ensure adherence to corporate policies/standards and applicable cGMP regulations for Quality Systems and Compliance, QualityAssurance, Quality Engineering and Quality Control.
• Build a diverse, high performing functionally independent Quality team with clearly defined roles, responsibilities, and reporting lines. Mentor and develop team members to ensure team agility, versatility, and expertise redundancy.
• Provide compliance expertise and guidance; interpret global drug regulations.
• Collaborate with other Quality leaders and stakeholders across the network. Assist in the implementation, continuous improvement and lifecycle management of implemented cGMP policies and quality management systems.
• Oversee and/or contribute to the development and execution of Quality Agreements with clients. Responsible for the timely and compliant delivery of site's responsibilities in accordance with Quality Agreement requirements.
• Responsible for product disposition to clients. Assure timely notification, investigation, and mitigation of quality events, with timely implementation of corrective actions and solutions.
• Lead site audit and regulatory inspection readiness plan. Responsible for client audits and regulatory inspections. Ensure timely and compliant responses and resolutions of identified deficiencies.
• Manage the sites regulatory compliance training programs to ensure sufficiently trained resources with adequate product and process knowledge for execution. Champion initiatives for continued learning and development.
• Represent site Quality in corporate planning and joint client-Resilience forums, as applicable.
• Ensure a stable and effective quality management system. Prepare and host periodic site Quality Management Reviews to assess the health of the Quality Systems; identify unfavorable trends and collaborate with stakeholders to ensure their timely mitigation. Contribute to the periodic corporate Quality Management Review, advocate continual improvement, and ensure a harmonized implementation of risk mitigation initiatives.
• Develop and manage departmental goals and corresponding budget in alignment with corporate vision and goals.
• Stay abreast of regulatory expectations, including technological advances and changes to industry standards. Advise site leaders and Quality organization on regulatory changes. Promote awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

Minimum Qualifications:

• Substantial experience in quality leadership within an FDA-regulated pharmaceutical environment. With expertise in managing quality roles within a manufacturing quality unit, particularly in cell culture bioprocess manufacturing.
• Ability to apply extensive knowledge in cell culture bioprocess manufacturing and analytical technologies in quality system design and investigations.
• Comprehensive knowledge of global GMP regulatory requirements.
• Experience with managing regulatory agency inspections.
• Proven record with building and leading high performance Quality teams as a leader of other leaders.
• 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-paced environment, collaborating across corporate functions and multiple stakeholders.
• Excellent communication and presentation skills.
• Strong interpersonal and influencing skills, with demonstrated capability in inspiring and leading cross-functional efforts.

Preferred Qualifications:

• Bachelor's degree or higher in Biology, Microbiology, Chemistry, or related field.
• Prior experience in quality for aseptic fill/finish manufacturing preferred.
• Prior experience in design and qualification of plant expansions preferred.
• CDMO site quality leadership experience is highly preferred.
• Experience with facility commissioning and qualification.
• Operational excellence experience preferred.
• Broad cross-industry operations management experience helpful.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.