Manager, Quality

About the role

This position will manage the Quality Management System activities of Bio-Techne's Wallingford site, including document control, training, validations, CAPA, NCMRs, deviations, and more. The role leads the qualification process for new processes and improvements, and may assist with software validation.

Responsibilities

• Manage personnel in the department, providing guidance, tools, and conducting performance discussions.
• Write, review, and approve SOPs, COAs, deviations, and change impact assessments.
• Ensure compliance with the Wallingford Quality Management System.
• Lead processes to resolve product and process-related issues, non-conformances, and optimization.
• Identify and implement process improvements and lead quality management system reviews.
• Approve all new and updated process validations.
• Collaborate with development teams to facilitate new product and process design and validation.
• Follow and comply with all company safety, quality, and training procedures and regulations.
• Perform additional duties as assigned.

Requirements

• Bachelor’s degree and 8+ years of relevant experience, or Master’s degree in a related field and 2–5 years of relevant experience.
• Demonstrated leadership capacity with 3–5 years of formal or informal leadership experience.
• Working knowledge of Microsoft Word and Excel.
• Ability to work in a fast-paced environment, prioritizing work to meet project deadlines.
• Strong analytical skills to make effective decisions.
• Excellent verbal and written communication skills, especially across different groups.
• Strong organizational skills and attention to detail.
• Ability to work independently and make strategic decisions.
• Proficient in planning, organizational, and multi-tasking skills.
• Ability to effectively train new employees.
• Ability to lead new projects across different groups.
• Must stay informed of current trends and developments in area of expertise.

Working Conditions

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.
• Standard schedule hours with occasional variation depending on production needs.
• Onsite work required during standard business hours.

Physical Requirements

• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.
• Manual dexterity required for laboratory equipment and fine measurement techniques.
• Ability to work at a computer for extended periods.
• Ability to lift and handle materials weighing 5–20 lbs.

Benefits

• Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet insurance, legal, and ID shield.
• Financial benefits: 401k, Employee Stock Purchase Plan (ESPP), Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Career development: mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• Employee engagement: resource groups, volunteer paid time off, employee events, and charity drives.
• Accrued leave policy: paid holidays, paid time off, and paid parental leave.

Pay

Pay Range: $91,700.00 – $150,800.00