Senior Manager, Quality Control (Microbiology) Days

Location: Bloomington
Posted on: June 23, 2025

Job Description:

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Responsible for leading the QC Microbiology & Biochemistry department to ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Manage the QC Microbiology Laboratory testing, processes & personnel. Relationships Sr. Director, QC Essential Functions Maintain cycle plan to meet customer needs & service level agreements. Ensure accuracy & scientific soundness of lab data. GMP Compliance of Lab. Leading team in successful execution of the microbiology & biochemistry testing process for Water, Raw Materials, API & Finished Product. Leading team in successful execution of the microbiology & biochemistry testing process for Water, Raw Materials, API & Finished Product. Effectively leading through others as a second line leader. Coordinating with the Sr. Director, Quality Control & EM & other teams on workload issues & priorities. Oversee successful transfer or verification of methods from Manufacturing Development laboratories. Ensure tracking & reporting of KPI’s. Lead initiatives to drive process improvements within respective department. Communication & collaboration with stakeholders. Responsible for ensuring department documents are current & standardized. Support training & development of QC Microbiology & Biochemistry personnel. Provide guidance for & approval of Laboratory Investigations & deviations. Oversee & provide guidance in systematic problem solving for re-runs & equipment-related issues. Other accountabilities, as assigned. Lead team members to improve and reinforce performance of others Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development Follow all safety and environmental requirements in the performance of duties Other duties as assigned Microbiology Accountable for daily operations to maintain Quality standards and project timelines, including execution of work, coordination with stakeholders, and communication with leadership Accountable for collaboration with internal stakeholders to complete microbiological analyses, maintain effective and efficient processes, and ensure appropriate test directives are established and followed Accountable for oversight of microbiological compendial method verification Accountable for completion of qPCR/PCR method development, qualification, validation, and execution Accountable for daily operations of the site’s environmental monitoring program Accountable for collaboration with internal stakeholders to complete environmental monitoring, maintain effective and efficient processes, and ensure appropriate test directives are established and followed Accountable for trending and reporting of site environmental monitoring data Support instrument onboarding and maintenance Stability Accountable for daily operations to maintain Quality standards and project timelines, including execution of stability testing, coordination with stakeholders and communication with leadership Account for oversight of sample management team Accountable for collaboration with internal stakeholders to complete stability analyses and reports, maintain effective and efficient processes, and ensure appropriate test directives are established and followed Accountable for monitoring stability protocol creation, stability sample pulls, testing completion, and stability report issuance Release and In-Process Accountable for daily operations to maintain Quality standards and project timelines, including execution of release and in-process testing, coordination with stakeholders, and communication with leadership Accountable for collaboration with internal stakeholders to complete release and in-process analyses and reports, maintain effective and efficient processes, and ensure appropriate test directives are established and followed Accountable for completion of release Certificates of Analysis Accountable for oversight of contract testing laboratories Accountable for Quality Control data review function for routine testing Supports instrument onboarding and maintenance Method Validation Accountable for daily operations to maintain Quality standards and project timelines, including execution of method validation work, coordination with stakeholders and communication with leadership Accountable for collaboration with internal stakeholders to complete method validation and qualification work, maintain effective and efficient processes, and ensure appropriate test directives are established and followed Accountable for completion of method qualification/validation protocols and reports Responsible for analytical method expertise within department Physical Requirements Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Development Of People Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way. Qualifications Bachelor's Degree in microbiology, biological sciences, or related field of study or equivalent combination of education & experience required. Minimum of seven (7) years of leadership/management experience in a clinical or industrial/pharmaceutical microbiology laboratory required. Minimum five (5) years Quality Control experience in an FDA regulated environment required. Knowledgeable in the following: Microbiological testing, GMPs & laboratory techniques required. Must demonstrate attention to detail, proofreading required. Strong computer skills with a willingness to learn new IT applications required. Environmental monitoring experience in aseptic environment preferred. Isolator & ELISA experience preferred. Microorganism identification by DNA/RNA or related advanced techniques preferred. Strong communication skills (verbal & written) are preferred. Ability to author scientific & technical reports preferred. Must be able to read and understand English-written job instructions and safety requirements Technical Requirements Excellent written and verbal communication skills with internal and external customers Provides technical support to their direct reports Ability to communicate complex technical information to non-technical audiences Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines Leads regulatory and client audits as a Subject Matter Expert Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process Experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones Well organized with ability to handle and direct multiple activities across departments simultaneously Behavioral Requirements Shares own ideas in a compelling manner that gains commitment from others Inspires and persuades others to voluntarily follow direction Negotiates skillfully and professionally and persuades others to approach issues in the same manner Wins concessions while building relationships or knowing when to yield to another's point of view. Teaching team the art of persuasion Anticipates the reactions and positions of others and plans accordingly. Mentors team to do the same Takes a proactive approach to shape and influence internal and external executive stakeholder expectations Serves as a liaison between different stakeholder groups across departments Effectively aligns and influences the interests of multiple stakeholders (client programs and company) with different priorities to quickly drive complex decisions Ability to see and hear, read, and write clear English Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time Ability to cooperate with coworkers within an organized team environment or work alone Detail oriented with ability to work effectively under high pressure with multiple deadlines Strong ability to multi-task in a fast pace environment Positive attitude and ability to work with others Ability to process a large volume of work Ability to effectively carry out and implement change Ability to put aside personal opinions and focus on business needs, department needs, or group needs Leadership Requirements Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline Manages strategic or continuous improvement activities with the team, across teams within the department, or across multiple departments within the site. Coordinates with teams in other departments and across the business unit. Helps identify department objectives to align with site goals. Regularly communicates to team, department, and company about department priorities and how aligned Makes implementation plans and assignments that allocate cross functional resources appropriately to complete objective and provide development opportunities Anticipates challenges and opportunities and adjusts contingency plans for department initiatives and team's project Identifies initiatives with relevant milestones and schedules to effectively manage the progress and performance of the team and own work developing metrics to monitor performance to goal Establishes an effective, professional, and positive relationship with employees Clarifies responsibilities and expectations and holds employees accountable Participates in and conducts timely HR-related processes Provides timely constructive feedback that is clear and direct Provides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performance Uses appropriate methods and flexible interpersonal style and coaching to develop others’ capabilities Recognizes and reinforces developmental efforts, progress, and improvements Collaboratively works with direct reports to set meaningful performance objectives We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Keywords: , Bloomington , Senior Manager, Quality Control (Microbiology) Days, Science, Research & Development , Bloomington, Indiana