Senior Validation Manager

What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world-changing projects, you will do more and become more than you ever thought possible.
Position Summary:
Direct and drive validation activities for all Consumables platform, NPI activities, and automation system to achieve a high level of manufacturing efficiency. Lead improvement initiatives on validation procedure and processes by working with cross-functional teams. Plan strategy for team to grow capabilities and value to enable fast turnaround for protocol and validation report closure.
Position Responsibilities:
Lead a team of Validation engineers to ensure validation protocol, quality, and projects are delivered on time
Provide advice and coaching in the resolution of validation challenges and issues, promote unity and cooperation to move things forward
Define and ensure Key Performance metrics on validation work under her ownership are monitored and reviewed regularly
Lead validation improvement initiatives and influence cross-functional teams, including Global teams to buy-in
Strategize workgroups OPEX spending and budgeting as well as manpower planning to support NPI and sustaining (RUO/Dx)
Provide leadership to consult, advise, and leverage practices to other departments performing validation activities
Support in internal and external audits, QMR, and oversee Site VMP.
Promote and enhance cross-site and cross-functional relationships, keeping communication open and seeking to understand constraints
Manage team development through training, coaching, and career mapping and career development, holding accountability to do the right thing
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
Bachelor's Degree in Engineering or Science or equivalent field of study
Minimum 12+ years of relevant work experience in Validation, with 3-6 years of people management experience
Knowledge in ISO13485, MDSAP & MDDAP
Strategic thinking with abilities to make recommendations and improvements
Managers at this level may become involved in elevated issues arising from daily activities
Ability to apply broad management, functional expertise/knowledge to subordinates managers and staff members
Will have developed key relationships with important customers and suppliers
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics.
We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.
We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
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