Job Description

Hiring an Executive Director, Quality Control Operations who has substantial experience leading Commercial Quality Control in Pharmaceutical or Biotechnology companies. The candidate will be a strong and action-oriented leader, who takes ownership and accountability for the testing and release of all drug products. You will manage and grow a talented QC Operations team that is responsible for performing environmental monitoring, in-process, final release, and stability testing and release of drug products.

Open to considering out of state candidates.

Responsibilities:

• As a member of the Senior Leadership Team, you will help guide the group through short- and long-term objectives.
• Ensure that all lot testing and release activities are efficient, coordinated for each lot, and executed as planned.
• Ensure that QC quality record requirements and targets are met and tracked.
• Ensure that reporting functions are adequately organized, supervised, and staffed. Intervene, where necessary, to expedite decision making or to meet target timelines.
• Ensure successful method transfer, qualification, validation, and training.
• Provide technical direction to, and gain alignment across, functions who are problem solving. Contribute to strategic and tactical decisions based on sound Quality principles and available data.
• Cultivate a culture of quality and shared accountability throughout the organization to help ensure compliance with applicable regulations, guidelines, corporate standards, policies and procedures.
• Drive corporate and department objectives to completion through strong collaboration with colleagues, other internal functions, and vendors.
• Ensure that the facilities are prepared for state, regional, or country authority inspections.
• Participate in Quality Management Reviews, Quality Councils, Quarterly Business Reviews to driver performance based on data and metrics.

Qualifications

• Bachelor's degree in Scientific Discipline or related discipline.
• 15+ years’ experience in the Pharmaceutical/Biotechnology industry, with extensive leadership experience in commercial Quality Control roles.
• Cell therapy experience required.
• Experienced overseeing US and EU commercial manufacturing.
• Expert knowledge of Health Authority expectations and industry practices in the US and Europe.
• Expert knowledge of FDA and ICH GxP regulations and guidelines.
• Effective negotiation, communication, listening and writing skills.
• Exceptional ability to develop open, candid, and collaborative working relationships with diverse stakeholders including C-Suite.
• Strong scientific and technical expertise with the ability to analyze a wide range of complex data.
• Has the credibility and reputation to attract and retain top talent and have a history of creating high-performing teams.

Salary

• $180,000-$200,000

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

Job Tags

Similar Jobs