Sr. Director- Analytical, Quality, and Development Services

Kindeva Drug Delivery; Woodbury (MN); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Director for Quality in their Analytical and Development Services unit. This pivotal leadership role involves overseeing quality operations, ensuring compliance with regulatory standards, and driving enterprise-wide quality strategy. The ideal candidate will have over a decade of experience in the pharmaceutical or medical device sectors, showcasing exceptional leadership and strategic thinking skills. This position offers the flexibility of remote work with global travel opportunities, making it an exciting chance to influence quality practices across multiple sites. Join a team dedicated to making a difference in patient health and well-being.

Qualifications

• 10+ years of leadership experience in the pharmaceutical or healthcare industry.
• Proven expertise in quality systems and regulatory compliance.

Responsibilities

• Develop and execute a unified quality strategy for the ADS business unit.
• Lead quality efforts across Analytical Services, PLM, and Risk Management.

Skills

Leadership in Pharmaceutical Industry

Quality Systems Expertise

Regulatory Compliance (FDA, GMP)

Strategic Thinking

Interpersonal Communication

Education

Bachelor's Degree

Advanced Degree (Pharmaceutics, Engineering)

Job description

Senior Director, Quality for Analytical and Development Services

09 April 2025

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 is a pivotal leadership position within Kindeva’s Analytical and Development Services (ADS) business unit, overseeing quality operations across the organization, Product Lifecycle Management (PLM) processes, and the Woodbury site. 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 laboratory and product development services and the ability to manage a diverse portfolio of delivery system platforms. The role also involves providing oversight to the Analytical Director, PLM and Risk Management Director, and multiple managers and principal-level scientists, ensuring alignment with business objectives.

The Senior Director, Quality reports to both the Vice President of Analytical Services and the Vice President of Quality, overseeing quality functions across all Kindeva sites. 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.
• PLM & Risk Management: Oversee the PLM and Risk Management Director in implementing robust design control, risk management, and design transfer processes.
• Team Leadership: Lead a team of managers and principal-level scientists, 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 with R&D, operations, and other functions to ensure quality integration across the product lifecycle.

Technical Expertise

• Provide guidance on regulatory requirements for drug delivery devices, 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.