Senior Manager, Quality Assurance and Regulatory Affairs

Published: 6/14/2022

Technology

Job Description

Senior Manager, Quality Assurance and Regulatory Affairs
Location: Zion, IL.
Salary Range: $125,000 - $135,000 +15% bonus
Employment Type: Direct Hire

Are you ready to lead at the forefront of regulatory compliance in a dynamic healthcare environment? Join as a Senior Manager, Quality Assurance and Regulatory Affairs, where your expertise will shape the safety, quality, and compliance of innovative OTC drugs and medical devices. This pivotal role offers the opportunity to oversee critical regulatory programs, drive continuous improvement, and collaborate cross-functionally to ensure our products meet the highest standards of excellence and safety.

In this hands-on leadership position, you will own and enhance our regulatory compliance initiatives, manage vital CAPA and NCR systems, oversee post-market surveillance activities, and prepare the organization for FDA inspections. Your strategic oversight will support a complex import-heavy supply chain sourced from Asia and India, making your impact truly global. Partner directly with senior leaders, mentor a talented team, and contribute to the evolution of our Quality Management System.

Key Skills & Qualifications:

Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or related field; advanced degree preferred
Minimum of 7 years of progressive QA/RA experience, with at least 5 years in OTC drug regulation under 21 CFR Parts 210 and 211
Deep knowledge of FDA regulations, including 21 CFR Part 820 (QSR), drug monograph requirements, and labeling standards
Proven track record managing FDA registration, drug listing, device listing, and GUDID submissions
Strong experience supporting or leading FDA and third-party inspection responses
Practical FSVP and foreign supplier qualification experience, especially in Asia and India
At least 3 years managing direct reports
Regulatory Affairs Certification (RAC) or equivalent certifications are a plus

Nice-to-Have Skills:

Experience with DSCSA compliance and MDR reporting under 21 CFR Part 803
Familiarity with eQMS platforms such as QT9
Experience managing external QMS consultants and compliance remediation projects
Knowledge of state pharmacy licensing and multi-state distribution regulations
Background in a distributor, contract manufacturing, or virtual manufacturer environment

Other Requirements:

Ability to operate across office and warehouse environments, including walking warehouse floors and occasional lifting up to 25 pounds
Willingness to travel domestically and internationally up to 20%, including supplier audits and industry meetings

Take this exciting step in your career to influence regulatory excellence and ensure the integrity of healthcare products that make a difference. Apply now and be part of a forward-thinking team committed to innovation and quality.

About Trova Advisory Group

Trova Advisory Group specializes in delivering a comprehensive array of staffing solutions tailored to meet the diverse needs of businesses across multiple sectors. Our expertise spans clerical, administrative, financial, and professional roles, offered through flexible arrangements including temporary, temp-to-hire, and direct hire services.

We pride ourselves on providing top-tier talent solutions that empower organizations to thrive in today’s competitive market.

Trova Advisory Group is proud to be an Equal Opportunity Employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, or any other protected status. We are committed to fostering an inclusive workplace where all individuals are welcomed and supported.

If you require reasonable accommodation during the application or interview process, please contact us at trova@gotrova.com. Include the nature of your request and your contact information.

Trova Advisory Group offers a comprehensive benefits package including medical and dental options for all eligible employees.

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