Boston Scientific Senior Quality Laboratory Manager 

United States, Minnesota 

300976191

About the role:

This position will work closely with Arden Hills site Operations, Supplier Quality, and Rhythm Management and Urology divisions to proactively plan laboratory resources to ensure new product development, process and material changes, sustaining improvement projects, and quality control testing demands will be supported today and in the future. Within the laboratory, this leader will drive strategic initiatives to improve quality, testing resiliency, test methods, culture, and resource planning.

Your responsibilities will include:

• Leads a team of employees in the achievement of organizational goals. Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Coaches, mentors, and develops direct reports on their career journey.
• Builds collaborative relationships with internal customers to understand current and future laboratory testing needs and priorities.
• Using project management skills, proactively plans resource allocations to align with project deliverables/testing demands and helps the team identify correct priorities when testing conflicts arise.
• Leads drug characterization and analytical chemistry team which conducts investigational and quality control testing; owns combination product drug batch release, retention, and stability testing programs.
• Supports the coordination and review of analytical chemistry testing conducted internally or at externally approved laboratories.
• Leads equipment support team which conducts equipment calibration and preventative maintenance activities to support the suite of equipment utilized by the Arden Hills Analytical Laboratory.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.
• Provides quality and/or management support for equipment control, software/equipment qualifications, test method validations, and process change assessments.
• Conducts laboratory investigations per Boston Scientific CAPA processes.
• Drive site or department level initiatives and strategic objective projects to improve culture, performance, agility, and compliance.
• Develops laboratory budget, business and quality metrics, and department goals. Manages adherence to budget and reviews their team’s metric and goals.

What we’re looking for:
Required qualifications:

• Minimum of a Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering or similar
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Minimum of 5 years of direct or indirect supervisory experience with a passion for leadership and team development
• Minimum of 2 years of laboratory or quality experience following cGMP and GDP requirements and principles
• Strong verbal and written communication skills, both technical and conversational
• Ability to utilize fundamental project management skills and tools for project and resource planning

Preferred qualifications:

• Advanced degree in Business, Chemistry, Biochemistry, Chemical Engineering or similar
• Pharmaceutical or drug combination product industry experience as part of laboratory or quality function
• Laboratory experience in liquid or gas chromatography analysis
• Medical Device or regulated industry experience
• Embraces a culture of proactive quality/compliance and continuous improvement
  

Maximum Salary: $ 232000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.