Director, Quality

Job Description

The Site Quality Head (SQH) is a senior leadership role responsible for 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 Site Quality Head will foster and pursue world-class 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 for the site.

The SQH has full direct operational control of Quality and will lead a team of up to employees across a variety of Quality sub functional roles.

The SQH will report to the Sr. Director, Quality, API with a matrix to the Site GM. This individual will be part of the Site Leadership Team in a critical and highly visible role supporting clinical and commercial manufacturing and testing operations. This leader will be a trusted partner to clients and business leaders across different functions to build a culture of quality within the site and serve as a role model by providing mentorship and coaching to all levels within the organization.

Key Responsibilities

• Encouraging 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 timely delivery through the lens of full compliance, driving this focus across the organization vital for efficient operations.
• Assess and progress an unparalleled Quality System on site in alignment with the PSG Quality Policy and Corporate policies and standards as a key differentiator for the organization.
• Optimize the Quality organizational model with the objective of growing our customer centricity and value; aligning roles and responsibilities.
• Translate the API business 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, establish a quality plan, related 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.
• Maintain awareness of all raised Quality matters and exercise sound, risk-based decision making in addressing these issues, working closely with the GM, Quality leaders, Legal and Business Relationship Management teams when concerns arise.
• 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.
• Mentor and guide the Quality team 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 functional leaders to ensure sharing of standard processes, sound application of strategic goals, demonstrating “expertise,” and alignment for our clients as a global business.

Minimum Requirements/Qualifications

• Bachelor’s degree in a life science field, advanced degree highly preferred.
• Minimum of 15 years related progressive experience, to include a minimum of 5 years of people management/direct leadership experience. Understanding of the API manufacturing process in GxP environments.
• Considerable hands-on experience interacting with FDA, global 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 approach.
• Demonstrated success in mentoring 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, empower and influence others within a remote team. Builder of teams, 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.
• Strong leadership skills with the ability to get the consensus of multiple partners.
• Track record of achieving results and proven ability to clearly identify and communicate a cogent vision; effectively manage through ambiguity and uncertainty, take appropriate risks and make sound and timely decisions.
• Embodies our Thermo Fisher values of Integrity, Involvement, Intensity and Innovation.
• Ability to travel based on business needs up to 30%, international and domestic travel.