Director, Quality - Product Testing & Lab Systems

Employer
Resilience
Location
Durham, NC
Posted
May 13, 2022
Ref
R-102212
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

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 Durham, NC.

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)
  • 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.