The Quality Leader, Advance Therapies (ATx) is a senior leadership role responsible to ensure that the important medicines needed by our customers are manufactured safely for patients around the world ensuring products meet Quality standards, Regulatory requirements and customer expectations. The BU Sr. Director Quality will champion and pursue extraordinary quality and promote a Quality culture. This role will provide strong leadership and strategic direction for overall quality operations, systems and compliance and quality control functions for the ATx organization.

ATx comprises facilities located in both the US and Italy, offering end-to-end Microbial Manufacturing, Cell and Gene Therapy, and mRNA CDMO services from process and analytical development to clinical and commercial supply of plasmids, cell or gene therapy, and vaccines. The Quality leader has full direct operating control of Quality for each site and will lead a team of up to 200 employees across a variety of Quality sub functional roles.

The Quality leader will report to Vice President Quality, for Pharma Services Group, and a matrix to the ATx VP/GM. This individual will be part of ATx leadership team in a critical and highly visible role supporting clinical and commercial manufacturing and testing operations. This Quality leader will work closely with their team to implement company priorities and partner with the full ATx Leadership Team to drive initiatives that are closely aligned with regional and go-to-market strategies, as well as customer and employee needs This leader will be a trusted partner to business leaders across different functions to build a culture of quality within the site and serve as a role model by providing guidance and coaching to all levels within the organization.

Key Responsibilities

• Fostering a right-first-time culture across operations.
• Develop short and long-term plans to achieve both quality and business objectives.
• Emphasize the critical need for on-time delivery through the lens of full compliance, driving this focus across all levels of the organization.
• Ensuring inspection readiness of operations, including preparation to regulatory inspections
• Interface directly with FDA, EMA and other regulatory authorities and ensure the company is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities.
• Develop resource strategies, allocate budget, staff, tools and specialized support necessary for efficient operations.
• Assess and progress an unparalleled Quality System within ATX- BU as a key differentiator for the organization.
• Optimize the Quality organizational model with the objective of increasing our customer focus and value; aligning roles and responsibilities.
• Translate Advance Therapies strategy to programs and goals for the function; ensure execution and delivery of such programs.
• Collaborate with Operational and Functional peers to formulate short and long-term quality objectives for the ATX- BU; establish critical metrics and accountability measures by which performance can be assessed regularly across the Quality Function.
• Use scientific judgment to develop solutions, and drive risk analysis and mitigation strategies.
• Ensure appropriate and efficient systems are in place for investigation and follow-up of non-conformances and quality issues, such as complaints, deviations, OOS results, or audit observations; ensure timely closure of any corrective and preventative actions.
• Accountable for the development, maintenance and management of quality systems that conform to applicable cGMP regulations.
• Coach and guide the Quality teams to ensure that the above activities are implemented and aligned across the business globally.
• Maintain influential relationships with clients and suppliers.
• Establish effective relationships with peer GMs, site leads and ATx functional leaders to ensure sharing of best practices, sound application of strategic goals, demonstrating “expertise,” and alignment for our clients as a global business.
• Make connections and maintain relationships across the company to maximise value to our customers.

Minimum Requirements/Qualifications

• Bachelor’s degree in a life science discipline, advanced degree highly preferred.
• Minimum of 20 years related progressive experience, to include a minimum of 5 years of people management/direct leadership experience. Understanding of the Plasmid, Cell and Gene, and/or mRNA manufacturing process in GXP environments.
• Considerable hands-on experience interacting with health authorities, especially related to regulatory inspections and follow-up.
• Experience managing within a matrix environment. Demonstrated ability to collaborate and navigate across the globe effectively with solid business results.
• Strong influencing skills, internally and externally, demonstrated within prior work environments.
• Experience working effectively with clients in regulated environments.
• Excellent communication skills, ability to build productive relations.
• Strong drive to challenge thus improve processes continuously.
• Strong problem-solving skills and the ability to make timely, risk-based decisions.
• Focus on patient needs and a client-centric mentality.
• Demonstrated success in coaching teams through internal and external challenges, preferably in a matrixed culture.
• Multi-cultural exposure and understanding; experience to work in and with global teams.
• Ability to lead, motivate and influence others within a remote team. Highly hardworking at team building, coaching and mentoring with a passion for encouraging others at all levels of the organization.
• Experience in developing others through personalized development plans with a track record of developing future leaders.
• Embodies our Thermo Fisher values of Integrity, Involvement, Intensity and Innovation.
• Ability to travel based on business needs up to 40%, international and domestic travel.

The salary range estimated for this position based in California is – $160,100 - $240,000 USD.

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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