Director of Quality

Job Summary

In this role, you will lead the development and execution of the quality assurance strategy for the West, Indiana site. You will oversee all aspects of quality systems, compliance, assurance, control, and continuous improvement to ensure adherence to regulatory requirements, corporate quality standards, and customer expectations.
As an integral member of the Site Leadership Team, you will align quality initiatives with business objectives and operational performance goals. Your responsibilities include oversight of drug packaging operations, combination product manufacturing, and investigational medicinal products (IMP), while fostering a culture of quality, continuous improvement, and operational excellence.

This position demands transformational leadership on a rapidly growing campus recognized as a center of excellence with significant expansion plans. Success in this role requires strong engagement with both local and global leaders to deliver innovative, compliant, and scalable quality solutions

Essential Duties and Responsibilities

Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact.

• Serve as a key member of the Site Leadership Team, actively contributing to strategic planning, achievement of site objectives and decisions to ensure patient safety and product quality

• Direct and lead the Quality function for combination medicinal products, investigational medicinal products (IMP), and medical device products/components molded, assembled, and packaged at the Indiana site
• Act as Head of Quality Control, Head of Quality, and Official Correspondent in accordance with US and regional legislation for all government agency authorizations, communications, and registrations.
• Develop and execute the site quality strategy, ensuring alignment with corporate objectives and regulatory requirements.
• Ensure site adherence to GMP, ISO 13485, FDA, EMA, and other applicable regulations for medical device, drug packaging and combination products.
• Direct Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams, ensuring strong engagement with internal stakeholders (Program Management, Operations, Engineering, Supply Chain, Continuous Improvement etc.).
• Maintain readiness for regulatory inspections and customer audits; lead site responses and remediation plans.
• Oversee the implementation and maintenance of the Quality Management System (QMS)
• Build and maintain strong relationships with customers, ensuring alignment and compliance with all customer Quality Agreements, specifications, and contractual obligations.
• Represent QA in customer steering committees and business reviews, chairing meetings on Quality standards and expectations.
• Manage customer satisfaction processes, monitor performance against agreed standards, and drive corrective and preventive improvements where discrepancies are identified
• Establish and monitor Quality KPIs, providing regular progress updates to senior management.
• Manage the quality departmental budget.
• Accountable for final product disposition and batch release decisions for medical device components, sub-assemblies, and combination products.
• Act as Management Representative, ensuring implementation and integrity of the Quality System.
• Collaborate with global quality teams to harmonize standards and share best practices.
• Inspire a culture of innovation and quality excellence, embedding it into the organization’s DNA.
• Lead by example, setting high standards for employee engagement and communication.
• Champion talent development, supporting local and global programs.
• Perform other duties as assigned based on business needs.

Additional Responsibilities

As an early member of our newest West site, you will thrive if you can:

Why Join Us:

• Adaptability and Collaboration: Thrive in a fast-paced, evolving environment where priorities shift; embrace change, ambiguity, and innovation while supporting cross-functional initiatives.
• Positive and Proactive Mindset: Bring a can-do attitude, show initiative, and take ownership—even in areas beyond formal responsibilities.
• Teamwork and Shared Goals: Work hard, stay flexible, and collaborate to achieve company objectives, fostering a culture of learning, problem-solving, and continuous improvement.
• Commitment to Quality and Values: Take pride in producing high-quality products that improve patient lives, while living core values of integrity, teamwork, and accountability.
• Growth and Entrepreneurial Spirit: Contribute to building a state-of-the-art facility from the ground up, grow your career in a dynamic environment, and ideally have experience in start-up or entrepreneurial settings

Education

• Bachelor’s Degree in either Quality, Engineering, Life Sciences or equivalent experience required
• Master’s degree a plus

Work Experience

• Proven experience in Medical Device, Pharmaceutical Packaging and Combination Products regulations e.g., ISO13485, US FDA Regulations -21 CFR Part 820, 210/211 and Part 4
• Minimum of 10 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
• Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements
• Proven track record of implementing process improvements and ensuring compliance with regulatory standards.

Preferred Knowledge, Skills and Abilities

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards: Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.

Additional Requirements

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971, US FDA 21 CFR Part 210/211 and Part 4.
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy #LI-JJ1

Travel Requirements

Physical Requirements