Site Quality Head, Alachua (Relocation)
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
The Site Quality Head is accountable for the quality oversight of the GMP operations at the manufacturing plant located in Alachua, FL. The Site Quality Head is a key leadership role and reports to the Chief Quality Officer. The position will be onsite in Alachua, FL.
*Relocation assistance may be provided
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 Alachua 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. Responsible for 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.
Pharmaceutical, Biotechnology and/or CDMO industry experience, with significant experience in a senior quality organizational leadership role
Comprehensive knowledge of global GMP regulatory requirements
Experience with managing regulatory agency inspections
Proven record with building high performance Quality teams
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
Excellent oral and written communication skills
Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field
Hands-on experience with overseeing GMP operations at a vaccine and/or biologics manufacturing plant
CDMO site quality leadership experience is highly preferred
Experience with facility commissioning and qualification
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Physical Requirements: (rows or statements that are not required to perform the duties of the position)
This job requires the employee to perform the following physical activities:
- Use of fingers
- Repetitive motion
This job requires the employee to work in the following conditions:
- Temperature changes
- Activities occur inside and outside
This job requires exposure to the following:
- Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
- Narrow aisles or passageways.
This job requires the employee to perform the following type of physical work:
- Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
This job requires the following visual acuity requirements:
- preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
- determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).
This job requires routine or periodic use of respiratory protection:
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.
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.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 $190,000.00 - $261,250.00. 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.