Job ID: 3165729

Exciting Opportunity in the Pharmaceutical/Biotech Industry – Quality Manufacturing

Our esteemed client, a globally recognized leader in the healthcare sector, is currently seeking a qualified professional for a challenging role in Quality Assurance. With a multitude of accolades and awards, our client operates on a global scale, making a significant impact on healthcare worldwide.

Position Overview: Quality Assurance Manager – Downstream Purification

Location: Branchburg, New Jersey, USA

Job Description:

Fulltime Onsite with Paid Relocation

Our client, a renowned player in the pharmaceutical/biotech industry, is in search of a dynamic Quality Assurance Manager specializing in Downstream Purification. This pivotal role involves overseeing day-to-day quality operations to ensure compliance with Good Manufacturing Practices (GMP) in support of downstream purification activities.

Key Responsibilities:

  1. Operational Excellence:
    • Foster a positive Quality Culture with a strong on-the-floor Quality presence.
    • Provide strategic direction for complex operational challenges and business issues.
    • Safeguard data integrity for both paper-based and electronic systems.
  2. Compliance Management:
    • Evaluate and endorse change controls, risk assessments, excursions, and deviation investigations.
    • Propose and oversee the implementation of corrective and preventive actions (CAPAs).
    • Ready the site for regulatory inspections, managing and coordinating responses.
  3. Process Enhancement and Collaboration:
    • Review and authorize standard operating procedures (SOPs), batch records, specifications, and validation protocols.
    • Act as a key Quality representative on Lead Teams and other relevant forums.
    • Collaborate on cross-functional initiatives, ensuring timely completion.
  4. Leadership and Development:
    • Mentor, guide, and oversee staff performance and development.
    • Strategically plan, administer, and monitor departmental budgets.

Basic Requirements:

  • Bachelor’s degree in Chemistry, Biology, Computer Science, Engineering, or a related field.
  • Minimum 5 years of technical/Quality experience in a GMP regulated environment, with 2 years of management/leadership experience.
  • A minimum of 1 year of hands-on experience supporting protein purification processes in a laboratory or large-scale development setting.

Additional Skills/Preferences:

  • In-depth technical knowledge with an understanding of business linkages.
  • Proficiency in decision-making guided by policies and business plans.
  • Influential communication skills with internal/external stakeholders.
  • Thorough understanding of domestic and international GMP regulations.
  • Knowledge of data integrity, computer systems validation, and System/Software Development Lifecycle.
  • Experience leading medium/large scale process improvement projects.
  • Ability to thrive in a dynamic, fast-paced environment.

Other Information:

  • Approximately 10% travel required.
  • On-call availability required.

Job ID: 3165729

Job Type: Full Time
Job Location: Somerville
State: New Jersey

Apply for this position

Drop files here or click to uploadMaximum allowed file size is 60 MB.
Allowed Type(s): .pdf, .doc, .docx