Sr. Director of Global Sterility Assurance

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Job Description:Sr. Director of Global Sterility Assurance & Microbiology3M Health Care is now SolventumAt Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.The Impact You’ll Make in this RoleAs the Sr. Director of Global Sterility Assurance & Microbiology, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:Leading and developing the capabilities and competencies of the Global Sterility Assurance & Microbiology team by providing expert-level functional leadership, oversight, and direction to your team on medical device and combination product sterilization industry trends, customer requirements, regulatory standards, emerging technologies, and existing modalities including gamma, EO, steam, e-beam, x-ray, and VHP from new product development through post-market surveillance for all Solventum products and sites globallyDefining and leading Sterility Assurance strategies to ensure adequate capacities and capabilities for current volumes and forecasted growth for existing portfolios and all New Product Introduction projects, managing the allocation of sterility assurance resources and ensuring robust validation and qualification processes are implemented and maintained for all internal and external sterilization processesEnsuring ongoing compliance by establishing requirements for sterilization validation / requalification protocols and reports for EO and Gamma sterilization per ISO 11135 and 11137 sterilization standards, coordinating sterilization testing and results interpretation & documentation (bioburden, sterility, EO residuals, etc.) related to sterilization activities with contract testing laboratories according to applicable standards (ISO 11737, ISO 10993-7, etc.), supporting ongoing manufacturing including environmental monitoring, product release, EO re-qualifications, quarterly dose audits, and product changes related to microbiology & sterilization, and by providing subject matter expert-level sterility assurance support during external compliance and regulatory audits & inspectionsCollaborating with other functions on sterilization deliverables for regulatory submissions, and performing microbiological evaluations of product and processes by ensuring thorough and timely investigations and root cause analysis related to sterilization issues, while also maintaining effective Quality metric performance by defining and executing activities to enhance product sterility assurance, reduce process variances, and resolve signals and decreases in performanceProviding influential peer leadership as part of the Global Quality Assurance Leadership Team to drive organizational improvements in sterility assurance compliance, risk management, product and process quality, quality culture, and predictive quality using industry-leading technologies, systems, and improvement tools for process control & monitoring, structured problem solving, and trend analysis to create solutions for complex and multi-faceted problems To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:Bachelor’s degree or higher AND fifteen (15) years of Sterility Assurance and Microbiology experience in a in a private, public, government or military environment.ANDIn addition to the above requirements, the following are also required:Ten (10) years of leadership and management experience in the MedTech and/or Life Science industry demonstrating functional expertise, team leadership, compliance excellence, value improvement, and risk reduction.Additional qualifications that could help you succeed even further in this role include:Master’s Degree from an accredited institution in Microbiology or SterilizationSkills including, but not limited to, Competent Authority / Notified Body interaction and influence, external audit readiness & management, 3rd party sterilization service provider interaction and influence, sterilization process control & monitoring, continuous improvement, implementation of parametric release, and sterilization cycle definition & qualificationDemonstrated experience navigating and leading teams within environments of complexity, transformation, change, and disruption using objective decision-making, problem-solving, continuous improvement, and effective management skills to create momentum and deliver improvements and results in a dynamic and fast-moving environment by prioritizing personal workloads, as well as providing guidance, direction, and oversight to othersProven track record of outstanding organizational talent development, with significant experience transforming the value quotient and contribution of a service center modeled, global support function that uses a results-focused approach to effectively collaborate across functions, businesses, and geographic boundariesVerbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report team Work location: Remote – United States Travel: May include up to 33% Domestic & International Relocation Assistance: May be authorizedMust be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $259,007 - $316,564, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-RewardsResponsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.Solventum is an equal opportunity employer.  Solventum  will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.Solventum Global Terms of Use and Privacy StatementCarefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.Please access the linked document by clicking here, select the country where you are applying for employment, and review. 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