Director, Quality Control

General Company Description

RESILIENCE (National Resilience, 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.

Position Summary & Role (general description of the role, e.g., expectations, key milestones, impact)

This role is accountable for quality oversight of the Quality Control Laboratory, sample management, method validation, data trending, change controls and laboratory investigations. The Quality Director- Product Testing & Lab Systems is a key leadership role and reports to the Site Quality Head. This key role participates in site cross-functional operational leadership team meeting. The Quality Director- Product Testing & Lab Systems will also be responsible to communicate effectively to the customer and contract labs. This role is accountable for managing the QC laboratory operations and product testing at the manufacturing plant located in Alachua, FL.

Job Responsibilities (core responsibilities; include people management if applicable)

Accountable for the development and lifecycle management of the QC laboratory operations, including but not limited to sample management, in-process, release and stability testing, laboratory equipment maintenance, data trending, laboratory investigations, execution of method validation and stability study protocols.

• Raw Materials and Product testing (in-process, release, stability)
  • Acts as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for in-process, release and stability testing. Ensures compliance of selected QC laboratory equipment to Part 11 and Data integrity regulations and guidelines.
• Sample management and testing schedule management.
  • Primary point of contact for QC operations for Client projects. Acts as liaison with Clients for site specific QC operations. Oversight of contract testing labs (raw material and product)
  • Execution of Analytical method comparability studies
  • Retain sample storage and inspection.
• Management of site lab E-Systems workflows (EM, LIMS, LES, etc)
• Responsible for developing and reporting of QC related metrics e.g., sample TAT and release, invalid and OOS data,
• Execution of method transfer, validation, and compendial method verification
• Data review
  • Schedules, reviews data and oversees testing of materials, intermediates and drug products. Ensures timely completion of testing deliverables in accordance with commitments made to Clients and corresponding Quality Agreements.
  • CoA generation/issuance.
• Laboratory investigations management.
  • Providing expertise and support for product investigations, improvements to ensure continue compliance with regulations. Overseeing complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis, and risks assessments.
• Product Specifications & associated sampling plan.
• Method Performance monitoring.
• Critical reagents/reference standards & material management and qualification
• Technical support for Commissioning & Qualification and CSV including potential execution of test scripts (lab instrumentation and equipment)
• Lab coordination with Facilities & Engineering for preventive maintenance and calibrations (lab instrumentation and equipment)
• Accountable for recruiting talent and building a high-performance QC team. Mentors and develops personnel and ensures team’s agility, versatility and expertise redundancy. 
• Establishes requirements and develops on-the-job-training plans for the QC team. Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures.
• Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goal

• Develops user requirements and contributes to the validation and implementation of the Laboratory Information Management System (LIMS) and electronic laboratory notebook

• Responsible for the development and lifecycle management of site-specific QC standard operating procedures and associated records

• Provides input and manages execution of method validation and verification for testing conducted at the site

• Maintaining a safe, efficient, functional and compliant laboratory
• Sustaining a continuous state of inspection readiness.
• Directing the development, planning, implementation and maintenance of test methods, processes, and operations
• Developing and implementing strategies to continuously improve data management practices and assuring data integrity
• Actively influencing the development and formalization of corporate laboratory control standards and procedures
• Manage budget for department and project resources.
• Member of site operational cross functional leadership team

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

• Bachelor’s degree of higher in Life Sciences, Biology, Engineering, or related field
• Minimum of 15 years of pharmaceutical or biotechnology industry experience, with minimum of 7 years in a quality oversight function
• Comprehensive knowledge of global GMP regulatory requirements for quality control laboratory operations, data integrity, and stability protocols.
• Strong Bioassay expertise.
• Hands-on experience with oversight of GMP laboratory operations at a biologics facility
• Previous managerial experience, with proficiency in hiring talent and managing performance

Other Ideal Preferred Characteristics:

• Broad Quality and Regulatory CMC experience, including:
  • Knowledge of biotechnology development, processing and testing
  • Compendial test methods

• Project management and budget management skills
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders
• Proven record of building high performing teams and developing talent
• Experience with presentation of laboratory investigations reports and operations to auditors and inspectors
• Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders
• Ability to collaborate and manage conflict in a fast-paced environment, working across functions
• Excellent interpersonal, verbal and written communication skills
• Experience in application of lean methodologies and operational excellence to continuously improve Preferred qualifications are additional qualifications or experience that would make an individual ideal for the job. However, if the individual does not have these qualifications, it does not disqualify them from being considered for the job.

Physical Requirements:

This job requires the employee to perform the following physical activities:

• Repetitive motion
• Crouching
• Feeling
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Temperature changes

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.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

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.
• Operates motor vehicles and/or heavy equipment.

This job requires routine or periodic use of respiratory protection:

• N/A

Equal Opportunity Statement

At Resilience we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, inclusive benefits, and more.

Resilienceis Equal Employment Opportunity and Affirmative Action Employers. 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.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact: careers@resilience.comfor assistance.
Resilience welcomes all.

Resilience does not accept unsolicited headhunter and agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement withResilience