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System One Quality Assurance Manager (Pharmaceutical) in Allentown, Pennsylvania

Title: QA Manager (Pharmaceutical)

Location: Allentown, Pa

Schedule: M-F 8am-5pm

Type: Direct/Permanent + benefits

Start date: Immediate

Our client is a global leader in infusion therapy and pain management. They are searching for a dynamic leader with a robust background in pharmaceutical QA operations to spearhead transformative change within their organization. Are you ready to embrace a challenge that can lead to tremendous career growth?

As the Quality Assurance Manager, you will play a crucial role in implementing TrackWise, reviewing and refining quality protocols, and leading change control initiatives and CAPAs. Your expertise will be instrumental in ensuring regulatory compliance and enhancing the quality of our products, propelling them to unprecedented levels of excellence.

Responsibilities:

  • Manages programs and activities within the quality assurance functions of an organization.

  • Administers policies and programs ensuring that organizational products and processes meet established quality standards.

  • Participates in the development, implementation, and administration of an organizational quality management system and monitors progress against strategic quality related goals.

  • Manages the work of a team of analysts that collect data identifying potential quality failures, evaluate the quality of raw materials or components, in progress goods, processes, or operations, and implement and measure the impact of corrective actions.

  • Responsible for personnel actions including hiring, performance management, termination

  • Enforces regulatory compliance.

  • Conducts visual and physical inspections of company products and materials.

  • Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.

  • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.

  • Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.

  • Judgement is required in resolving complex problems based on experience.

  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

    Requirements:

  • Bachelor's degree required.

  • 6-8 years of pharmaceutical industry experience is required.

  • 2-3 years of leadership experience

  • Regular and predictable attendance

  • Occasional business travel required

  • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

    Our client offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

    #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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