Senior Director-Quality, Analytical Services

Kindeva Drug Delivery; Woodbury (MN); Remote; USD 150,000 - 200,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Senior Director in Quality, Analytical Services to oversee quality operations and drive enterprise-wide quality strategy. The successful candidate will bring extensive leadership experience and a strong understanding of regulatory compliance to foster a culture of innovation and excellence in quality management.

Benefits

Medical, Dental, & Vision Benefits

Health Savings Accounts

Flexible Spending Accounts

Disability Benefits

401k Benefits

Qualifications

• 10+ years of leadership experience in pharmaceutical, medical device, or healthcare industries.
• Proven expertise in quality systems, GMP compliance, and regulatory engagement.
• Experience managing large, cross-functional teams.

Responsibilities

• Develop and execute a unified quality strategy for the ADS business unit.
• Lead quality efforts across Analytical Services, PLM, and Risk Management.
• Maintain an inspection-ready state at all times.

Skills

Leadership

Strategic Thinking

Problem Solving

Communication

Collaboration

Education

Bachelor's degree from an accredited institution

Advanced degree in a relevant field

Job description

Senior Director-Quality, Analytical Services

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Senior Director, Quality, Analytical Services is a pivotal leadership position within Kindeva’s Analytical and Development Services (ADS) business unit, overseeing quality operations across the organization. This role is responsible for driving enterprise-wide quality strategy, ensuring compliance with regulatory requirements, and fostering a culture of innovation and continuous improvement.

This position requires expertise in analytical laboratory services and the ability to manage a diverse portfolio of delivery system platforms. The role also involves providing oversight to several directors and managers, ensuring alignment with business objectives.

The Senior Director, Quality reports to the Vice President of Analytical and Development Services and matrix dotted line reporting to the Chief Quality Officer. This role may be remote, with global travel as needed.

Essential Job Functions:

Strategic Leadership & Organizational Impact

• Enterprise Quality Strategy: Develop and execute a unified quality strategy for the ADS business unit, ensuring alignment with company-wide goals and regulatory standards.
• Cross-Functional Oversight: Lead quality efforts across Analytical Services, PLM, and Risk Management, collaborating with internal and external stakeholders to optimize delivery system platforms.
• Governance & Compliance: Establish governance frameworks to ensure clear communication, timely decision-making, and consistent compliance with cGMP and global regulatory requirements.

Oversight of Functional Areas

• Analytical Services: Provide strategic direction to the Analytical Director, ensuring the quality of lab operations and analytical testing meets or exceeds industry standards.
• Team Leadership: Lead a team of directors and managers, fostering a high-performance culture, driving staff engagement, and supporting professional growth.

Quality Operations Management

• QMS Development: Design and implement an efficient, compliant, and scalable Quality Management System (QMS) to support global operations.
• Continuous Improvement: Drive process improvements across the organization, leveraging metrics to identify risks and opportunities for efficiency.
• Inspection Readiness: Maintain an inspection-ready state at all times, managing internal and external audits and leading responses to regulatory inspections.

Stakeholder Engagement & Collaboration

• Customer Focus: Promote a culture of excellence and customer service, ensuring alignment with internal and external client expectations.
• Industry Leadership: Build and sustain relationships with regulators, customers, and industry stakeholders to support organizational growth and influence policy development.
• Cross-Functional Partnerships: Collaborate quality, operations, and other functions to ensure quality integration across the product lifecycle.

Technical Expertise

• Provide guidance on regulatory requirements for analytical testing, ensuring compliance with global standards.
• Oversee technical aspects of chemistry and physical testing to ensure adherence to quality objectives and facilitate innovation.

Basic Qualifications:

• Bachelor’s degree from an accredited institution
• 10+ years of leadership experience in pharmaceutical, medical device, or healthcare industries.
• Proven expertise in quality systems, GMP compliance, and regulatory engagement (FDA, MHRA, EMEA).
• Exceptional strategic thinking and problem-solving skills, with the ability to influence policy and organizational direction.
• Strong interpersonal and communication skills, with a track record of collaboration at executive levels.
• Demonstrated success in managing large, cross-functional teams and driving enterprise-level initiatives.

Preferred Qualifications:

• Advanced degree in a relevant field (e.g., Pharmaceutics, Chemical Engineering, Chemistry, Mechanical Engineering) preferred; Ph.D. is an advantage.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

The expected compensation range for this position represents a good faith estimate. 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, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

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