Group Leader Quality Assurance (Pharma/Biotech)

Company: Pace Life Sciences
Location: Morrisville
Posted on: February 6, 2025

Job Description:

About UsPace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Job Description SUMMARY Responsible for the day-to-day management of the technical section assigned, typically consisting of approximately four to ten technical staff members. They plan, coordinate, and direct the operations of the technical section assigned to meet client timelines, provide data of appropriate quality, and deliver analytical reports and protocols on time. They are responsible to assure that individuals operate within the quality system and drive individual productivity. ESSENTIAL FUNCTIONS

• Supervises staff including hiring, training, evaluating performance, providing compensation recommendations, and performance management.
• Ensures that all employees have the necessary training, tools, information, accessories and materials to properly and safely perform their job responsibilities.
• Oversees and supervises broad areas of the operations, such testing, scheduling, inventories, services, communication and general coordination of the lab, services, and field; provide basic technical and quality support to staff members and clients.
• Assign training, laboratory and facility duties. Monitor and review these activities to ensure they are being properly conducted and completed in a timely fashion.
• Clearly documents client requirements within the appropriate format (e.g. Deviations, Project Logs, Project Requirements).
• Acts as the main interface between Pace and the client; ensures that status and progress updates are presented to the client and management as necessary; assists with receiving customer feedback and coordinating resources and responses as required.
• Ensures the accuracy of tests and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.
• Assist in equipment and facility maintenance; investigate and facilitate the solving of any equipment/ facility problems.
• Participate in writing, reviewing and approving SOPs, calibration procedures, laboratory procedures, validation protocols, maintenance procedures and any other necessary protocols or reports as appropriate.
• Overseeing or reviewing, completing, and processing broad degrees of tests, forms, documents, databases, and related materials and information.
• Provides analysis, interpretation and counsel to staff, management, and functional leaders regarding lab, services, field or testing policies, programs, and practices; involves broad operations and leading implementation and change.
• Analyzes and reviews operations, results, feedback and related lab, services, field or testing information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.
• Assists with developing or participating in department or cross-functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management.
• Assures that the technical area is compliant with Pace's and general regulatory requirements; works closely with the Quality Assurance group to ensure that all quality procedures are being followed and enforced.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment. QUALIFICATIONS Education and Experience
  • Bachelor's degree in chemistry, biology, or a closely related field
  • Five (5) years of lab, services, field or testing experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience.
  • Two (2) years of team leadership is strongly preferred. Required Knowledge and Skills Required Knowledge
    • Strong interpersonal and leadership skills.
    • Strong communication and technical writing skills.
    • Very complex to specialized principles, practices and techniques in the lab, services, field or testing area.
    • Broad understanding of the administration and oversight of lab, services, field or testing programs, policies, and procedures.
    • Very complex to specialized methods to resolve lab, services, field or testing problems, questions, and concerns.
    • Broad understanding of applicable lab, services, field or testing laws, codes, and regulations.
    • Computer applications and systems related to the work.
    • Principles and practices to serving as an effective project team member.
    • Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
    • Correct business English, including spelling, grammar, and punctuation. Required Skills
      • Supervising and evaluating employees and providing related recommendations.
      • Training others in policies and procedures related to the work.
      • Performing very complex to specialized professional-level lab, services, field or testing duties in a variety of assigned areas.
      • Overseeing and administering broad and varied lab, services, field or testing functions.
      • Serving as a team member and the development and management of projects.
      • Operating in a both a team and individual contributor environment.
      • Interpreting, applying, and explaining applicable laws, codes and regulations.
      • Preparing very complex to specialized functional reports, correspondence, and other written materials.
      • Using initiative and independent judgment within established department guidelines.
      • Using tact, discretion, and prudence in working with those contacted in the course of the work.
      • Performing effective oral presentations to large and small groups across functional peers and the department.
      • Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
      • Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work. PHYSICAL/MENTAL REQUIREMENTS Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects.
        Additional Information Benefits 80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
        Work Schedule Monday through Friday, 8:00 AM - 4:30 PM

Keywords: Pace Life Sciences, Cary , Group Leader Quality Assurance (Pharma/Biotech), Other , Morrisville, North Carolina