Director of Quality & Regulatory Affairs

Director of Quality & Regulatory Affairs at LHH Director of Quality & Regulatory Affairs at LHH in Mundelein, Illinois Posted in 7 days ago.

Type:

full-time

Job Description:

LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Director of Quality & Regulatory Affairs -- Pharmaceutical & Medical Device Manufacturing to join their team. This is a high?impact leadership role suited for a quality professional who thrives in fast?paced, entrepreneurial environments and enjoys rolling up their sleeves to drive results. This opportunity offers the chance to serve as the senior quality and regulatory leader for a lean organization, with direct visibility and influence across manufacturing, engineering, and operations. The Director of Quality & Regulatory Affairs will lead all aspects of the Quality Management System and regulatory compliance strategy for the organization. This individual will act as the primary company representative to regulatory agencies, ensure ongoing FDA and ISO?13485 compliance, and develop a high?performing quality team capable of supporting current operations and future growth. This role requires a strong mix of strategic leadership and operational execution, with comfort working in a smaller organization where priorities can shift quickly and deadlines matter.

Key Responsibilities:

Lead, develop, and oversee the Quality Assurance and Quality Control functions, managing a team of approximately 10 direct reports, including quality leadership and quality and engineering staff. Serve as the primary point of contact and face of the organization with regulatory agencies, including FDA and certification bodies. Prepare for, lead, and host FDA inspections, ISO audits, and customer audits, including remediation activities as needed. Own and continuously improve the Quality Management System to ensure compliance with FDA regulations, ISO?13485, GMP requirements, and applicable quality standards. Drive CAPA, deviation investigations, complaint handling, and nonconformance management through effective root cause analysis and follow?through. Ensure validation programs are appropriately designed, executed, and documented, including equipment, processes, and systems. Collaborate closely with Manufacturing, Engineering, and Operations to embed quality into daily activities and meet aggressive timelines. Develop, train, mentor, and engage a junior to mid?level quality team, fostering accountability, ownership, and professional growth. Maintain audit?ready systems and documentation at all times in support of business continuity and customer confidence. Balance leadership responsibilities with hands?on execution to ensure work gets completed accurately and on time.

Qualifications and Skills:

Bachelor's Degree in a scientific or technical discipline. 7+ years of experience within pharmaceutical, healthcare, or medical device manufacturing environments. 5+ years of quality management or people?leadership experience. Demonstrated experience leading FDA inspections and responding to regulatory findings, including remediation efforts. Deep working knowledge of FDA regulations, ISO?13485, GMP, CAPA, and Quality Management Systems. Validation experience with a practical understanding of equipment, process, and system qualification. Prior experience acting as a direct liaison with the FDA or other regulatory bodies. Knowledge of aseptic filling operations is strongly preferred. Comfortable working in a smaller, agile organization where adaptability and accountability are essential. Highly operational leader who can delegate effectively while remaining hands?on as needed. Entrepreneurial mindset with a bias for action and follow?through. Confident communicator able to influence internally and externally at all levels. Proven ability to develop and strengthen teams through coaching, training, and engagement.

Compensation Range:

$150,000 - $200,000 + 25%

Bonus Benefits Offered:

2 weeks of vacation, paid sick leave where applicable by state law, Medical Insurance, Dental Insurance Vision Insurance, 401K, and Life Insurance. If you are a passionate Director of Quality & Regulatory Affairslooking for anew and rewarding career, please apply today! You don't want to miss out on this opportunity! LHH is a leader in permanent recruitment-and in the placement of top talent. Our areas of specialty include office administration, customer service, human resources, engineering, and supply chain and logistics. Please feel free to check us out and apply for other opportunities if this role isn't a perfect match. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.lhh.com/candidate-privacy/