Hiring: Director of Quality Company: West Pharmaceutical Services Location: Greenfield, IN Job Posted Time: 2026-09-10 14:02:07 Employment Type: On-site Target Skills & Keywords : Microsoft Excel, Program Management, Quality Assurance, Regulatory Compliance About the job 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. •Demonstrated success in implementing process improvements and ensuring compliance with regulatory standards. Required Skills: •This is an onsite position requiring the team member to be onsite 5 days a week. •There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. •We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. •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. •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 •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 Qualifications: •Bachelor’s Degree in either Quality, Engineering, Life Sciences or equivalent experience required •Master’s degree a plus •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. •Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making. •Excellent written and oral communication skills Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!