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
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.
- 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.
- 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.
- 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.
- Leadership and Development:
- Mentor, guide, and oversee staff performance and development.
- Strategically plan, administer, and monitor departmental budgets.
- 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.
- 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.
- Approximately 10% travel required.
- On-call availability required.
Job ID: 3165729