Director, Quality

Work Schedule

Environmental Conditions

Job Description

Reporting directly to the Global Head of Quality Large Molecules and dotted line to the General Manager for the site, leads, directs and manages the site’s Quality organization and all Quality related programs and activities to support site operations for clinical and commercial manufacturing, testing, and release of biopharmaceutical products. Ensures business, quality and compliance goals are met and in compliance to Global Quality policies and standards and relevant government issued quality and regulatory policies/ guidelines. Responsible for ensuring a comprehensive, robust and effective Pharmaceutical Quality system is in place and implemented throughout the organization. Demonstrates a continual improvement mentality with strong customer focus. Leadership position that will develop Quality strategy, make decisions based on relevant data and current Good Manufacturing Practices (cGMPs).

Responsibilities

• Ensure each batch of medicinal product aligns with all regulations, including approval or rejection of starting materials, intermediates, bulk, and finished products.
• Select, develop, and evaluate staff to guarantee flawless operation within the Quality function.
• Participate and lead in management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvement.
• Implement a timely and effective communication process to advance quality issues to the appropriate management levels.
• Manage and supervise the Quality Unit, assisting in the development of goals and key performance indicators.
• Actively collaborate as a member of the site leadership team, encouraging a culture of right-first-time quality and efficient execution.
• Establish and achieve the goals and objectives of the Quality team, ensuring delivery of high-quality analytical stability studies, transfers, qualifications, and validations within set timelines.
• Develop operating and capital expense budgets, ensuring the Quality organization contributes to overall profitability.
• Support the business in assessing new opportunities, providing quality input to prospective customers.
• Develop and maintain positive relationships with local, regional, and national regulatory authorities, providing leadership during health authority inspections and regulatory awareness programs.

Requirements

• Bachelor's degree and 7 years min quality experience.
• Proven experience in a senior Quality role within the manufacturing sector.
• Outstanding leadership skills with the ability to develop and encourage a high-performance team.
• Strong knowledge of regulatory requirements and quality systems.
• Analytical or quality control experience
• Excellent communication and interpersonal skills, with a collaborative approach to problem-solving.
• Ability to manage budgets and contribute to profitability.
• Experience in working with regulatory authorities and leading inspections.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards