Director, Quality Oversight – Contract Testing Laboratories

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Oversee the strategy, organizational design, budget management, and performance evaluation for contract testing laboratories and the cell bank quality oversight organization.

• Develop and uphold risk-based quality oversight frameworks for contract testing laboratories and cell banking operations.

• Deliver operational leadership to contract testing laboratories responsible for drug substance, drug product, and finished product testing.

• Ensure Quality oversight to confirm that products are tested, stored, and retained in compliance with regulatory expectations, GLP, GMP, and company standards.

• Manage the resolution of quality issues, out-of-specification investigations, and deviations that may affect launch or supply continuity.

• Provide Quality oversight for the transfer of analytical technologies.

• Establish performance expectations, metrics, and governance routines to track and enhance quality and operational performance.

• Conduct Quality assessments for potential contract test laboratories or new method citations, ensuring that identified gaps are addressed.

• Create and maintain Quality agreements.

• Lead, mentor, and develop a high-performing team of quality assurance professionals.

• Foster accountability, collaboration, operational excellence, and proactive problem-solving across both internal and external testing networks.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline is required.

• A minimum of ten (10) years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations adhering to global GMP and health authority guidelines.

• A proven history of managing complex quality investigations, assessing risks, and making prompt, data-driven decisions.

• A strong compliance background with experience in supporting regulatory inspections and interactions with health authorities.

• Demonstrated success in leading and developing teams.

• Willingness to travel approximately 30% of the time, including occasional short-notice trips.

• An advanced degree in a relevant scientific or technical field is preferred.

• Experience in leading external partners in the biologics or vaccines sector is preferred.

• Prior leadership experience in a multinational organization with direct accountability for partner performance, compliance, and supply support is preferred.

• In-depth knowledge of quality governance models, supplier oversight, and risk-based quality management systems is preferred.

• Experience collaborating with leadership at external partners to influence performance, enhance quality systems, and expedite remediation is preferred.

• Broader exposure to operations, engineering, supply chain, and commercial functions is preferred.

• Experience in leading transformation, standardization, or continuous improvement initiatives is preferred.

• Visa sponsorship is not available.

🏝️ Benefits

• Annual bonus and long-term incentive, if applicable.

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation time.

• Compassionate and sick leave days.

• Remote work arrangement.

• No relocation required.