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.