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| Job Category : | Management |
| Company Name: | Thermo Fisher Scientific |
| Position Name: | Sr. Director, Quality, Advanced Therapies (Remote/West Coast US) |
| Location : | San Diego, CA |
| Job Description : | Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing efficiency in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. The Sr. Director Quality, Advance Therapies (ATx) is a senior leadership role supporting the rapidly growing and evolving areas of cell & gene therapy, plasmids, and mRNA. The role is responsible to ensure important medicines are manufactured to the highest Quality standards for our customers and patients worldwide. The BU Sr. Director Quality will ensure a flexible and phase appropriate quality system that accelerates drug development, manufacturing, and regulatory approval pathway, while ensuing Quality and regulatory compliance. This role will provide strong leadership and strategic direction for Quality in the ATx organization. They has full 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. 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 BU Sr. Director Quality will report to the Group Vice President Quality, 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 and working in a fast paced and evolving technology and regulatory landscape. This BU Sr. Director, Quality leader will work closely with his/her team to execute 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 Foster a strong Quality culture. Translate Advance Therapies strategy to programs and goals for the Quality function; ensure execution and delivery. Develop and maintain positive company image and relationships with key customers, vendors, and regulators; will personally be involved with the management of key accounts; will represent the company as appropriate in its relationships with external entities. Maximise Thermofisher Quality system to implement a phase appropriate ATX- Quality System that ensures, compliance, agility and provides a key business differentiator. Understand and navigate the constantly evolving regulatory landscape and adapt the ATX Quality Systems and regulatory strategies accordingly. Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement. Responsible for Quality Management Review (QMR) and assure that there are no significant interruptions to the business due to quality or compliance issues. Ensuring inspection readiness of operations, including preparation to regulatory inspections. Use scientific judgment to develop solutions, and drive risk analysis and mitigation strategies. Interface regulatory authorities and ensure the company is appropriately represented in matters related to compliance and quality. Minimum Requirements/Qualifications Bachelor’s degree in a life science discipline, advanced degree highly preferred. Minimum of 20 years related dynamic 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 leading 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 mindset. 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. Apply today! http://jobs.thermofisher.com We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! |
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