Sr. Manager, Global Quality Systems-Remote

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X. 

Why join us?

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees.

Reporting to the Vice President of Quality, the Sr. Manager of Global Quality Systems, will lead and build a dynamic medical device quality systems team focused on standardizing and deploying best in class quality processes and communications across embecta worldwide. In addition to establishing and maintaining a compliant global quality system, this person will lead the engagement and interaction with key internal customers specifically Regulatory Affairs, Operations Quality, Design Quality, and Post Market Surveillance teams along with key external customers. This leader will drive alignment on quality related processes, targets, and goals. You will be a member of the global quality senior leadership team and support and lead global initiatives and ensure successful outcomes for global quality initiatives and programs. This role is crucial for ensuring consistent quality standards worldwide, maintaining regulatory compliance, and fostering continuous improvement to support embecta's mission of empowering people through innovative medical solutions.

Responsibilities

The Senior Manager of Global Quality Systems will be responsible for leading and managing the following activities:

• Leading a team of professionals executing quality processes at the global level such as; training compliance, Corrective and Preventive Actions (CAPA), and document controls.
• Ensure compliance with regulatory requirements and internal quality standards. This includes maintaining up-to-date documentation and records, conducting regular reviews, and implementing corrective actions promptly.
• Drive successful outcomes in all internal and external audits. Including preparing thoroughly for audits, addressing any findings swiftly, and continuously improving processes to prevent recurrence of issues.
• Implement quality improvement initiatives. The initiative should focus on enhancing quality compliance, efficacy and safety of embecta’s products by streamlining processes, and reducing process defects or non-conformities.
• Foster improvement in key quality metrics, such as defect rates, audit findings, and cycle times for issue resolution.
• Ensure embecta associates are compliant with training. This includes governance of training plans, tracking progress, and ensuring training is relevant and up to date.
• Positive feedback from internal and external stakeholders, highlighting the effectiveness and consistency of quality systems.
• Ensures the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization.
• Establish and/ or revise processes, procedures, and metrics to support the global quality system and processes.
• Establish excellent working relationships with quality, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations.
• Contribute to the achievement of site objectives by playing an active role in the strategic planning process including the development of quality targets for continuous quality improvement
• Monitors progress of the Quality KPI's and communicate it to the organization and senior management
• Develop the organizational structure and talent to execute the Quality imperatives while supporting the overall company needs.
• Facilitate FDA and ISO inspections and any external audits/assessments to ensure that the global Quality Management System is properly represented.
• Engenders cooperation between teams to enable issue resolution.
• Serves as a facilitator and mentor to subordinates and fellow co-workers, retain/build organizational talent.
• Successfully mentor and develop the quality systems team by providing training, guidance, and support, fostering a collaborative and innovative work environment.
• 15% travel will be needed for the role.
  
  

People Manager Core Competencies

• The ideal candidate will develop talent with integrity, transparency, and a focus on measurable outcomes. They will incorporate external perspectives, foster creativity, and collaborate effectively, ensuring inclusivity and continuous improvement. In organizational design and succession planning, they will maintain ethical standards, adapt to industry trends, and engage team members, promoting a culture of inclusivity. Effectively carries out the expectations of People Managers as defined in company’s people leadership expectations. Among others this includes maintaining regular, at a minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issues and conflict proactively uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team
  
  

Customer Focus

• The ideal candidate will prioritize the customer's perspective in strategic decisions, craft service practices that meet customer needs, and continuously seek ways to improve satisfaction. They will encourage experimentation, collaborate with team members, and value diverse customer perspectives.
  
  

Decision Making

• The ideal candidate will gather and analyze information ethically, consider external data, and make timely decisions based on clear criteria. They will involve team members and ensure decisions reflect diverse perspectives.
  
  

Driving Innovation

• The ideal candidate will inspire ethical innovation, encourage novel solutions, and promote experimentation. They will foster a culture of creativity, collaborate to drive innovation, and ensure inclusivity.
  
  

Emotional Intelligence Essentials

• The ideal candidate will establish trusting relationships, accurately interpret emotions, and manage responses effectively. They will continuously improve emotional intelligence skills, build strong relationships, and ensure practices remain inclusive and respectful.
  
  

Basic Requirements

• Bachelor of Science in a Scientific, Technology, Engineering, Mathematics or related discipline;
• 10+ years of experience in quality within the medical device, pharmaceutical, Biologics, or related FDA regulated industry.
• 5+ years in a leadership role with demonstrated progressive responsibility overseeing global quality systems.
• Proven experience in managing quality systems in a medical device or similar regulated company, including developing and implementing quality management systems complying with regulatory expectations worldwide.
• Demonstrated track record of ensuring compliance and successfully navigating regulatory audits.
• Experience supporting internal and external audits, including preparing for audits, addressing findings, and implementing corrective actions to improve processes.
• Demonstrated ability to drive continuous improvement initiatives, such as implementing Lean or Six Sigma methodologies to enhance product quality and operational efficiency.
• Experience working with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to integrate quality systems into all aspects of product development and manufacturing.
• Extensive knowledge of FDA and international regulations.
• Expertise in ISO 13485, and ISO 14971, including other relevant standards for embecta products.
• Fluent in the use and implementation of global technology platforms, such as Microsoft applications, SAP, and ETQ.
• Ability to manage multiple projects simultaneously, including planning, executing, and monitoring project progress to ensure timely and successful completion
  
  

Preferred Requirements

• Master of Science degree preferred.
• Preferred certifications include Six Sigma, ISO 13485, and ASQ Certified Quality Manager.
• Strong leadership skills with experience in mentoring and developing quality teams, fostering a culture of quality and continuous improvement.
• Expertise in identifying and mitigating risks related to product quality and regulatory compliance.
• Professional communication and presence
• Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.
  
  

Competitive base salary based on experience and qualifications: $137,100 - $181,650 (subject to variation depending on physical location).

Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate’s experience, qualifications, external market conditions, and internal equity considerations.

Base pay is one component of the Total Rewards package at embecta, which also includes eligibility for an annual bonus and an annual LTI award. Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page

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embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.