Director, Quality Assurance & Regulatory Compliance

Posted on October 02, 2025 (21 days ago)

Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and life experiences to help build the future of healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We look for team members who are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients, and the patients we serve. We are EVERSANA.

Job Description

The Director, Quality Assurance & Regulatory Compliance is responsible for establishing strategies, planning and development of quality and regulatory compliance processes and procedures. Ensuring EVERSANA is compliant with all applicable federal, state, and local regulations and standards, with a focus on Quality & Regulatory. They manage and direct the activities of the Quality & Regulatory Departments to ensure compliance with regulatory requirements and quality standards.

Quality Responsibilities:

Oversees Quality Assurance, setting quality goals and objectives consistent with business unit and management goals, as well as FDA/DEA, State Boards Pharmacy, Accredited Bodies, GDP and ISO Quality Standards, as applicable.
Promotes a company-wide culture of quality awareness and compliance understanding.
Serves as the Quality management representative for regulators, notified bodies, and customer audits.
Maintains knowledge of existing and emerging quality standards and regulations, interpreting and communicating changes.
Supports audit processes for Supplier Qualification and Maintenance and facilitates Supplier Selection process cross-functionally.
Experienced in selecting and qualifying GxP suppliers and managing related quality agreements.
Works with subject matter experts for technical review of controlled documents.
Reviews and approves documentation related to GxP activities outsourced to Qualified Suppliers.
Creates and updates quality assurance procedures and documentation systems.
Supports development of protocols for test method validations, design and process verifications, biocompatibility, sterilization, shelf life, stability, and risk management.
Develops and trains the Quality Assurance Unit staff.
Ensures quality through planning, monitoring, and appraising job results.

Regulatory Responsibilities:

Drives implementation and compliance with global regulatory requirements relevant to company services.
Leads development, implementation, and maintenance of regulatory processes at the business level.
Supports regulatory compliance strategy development.
Works with Business Unit Implementation Teams and commercial partners for regulatory licensure submissions alignment.
Acts as main liaison for channel management with regulatory authorities and consultants.
Understands related fields and solves complex problems collaboratively.
Monitors regional/global regulatory environment and communicates changes organization-wide.
Represents Regulatory function on project teams aligning regulatory strategy with team objectives.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

People Leader Responsibilities:

Member of the Senior Leadership Team, communicates Quality Assurance and Compliance information effectively internally and externally.
Establishes Quality and Regulatory Compliance strategies aligned with Business Unit objectives.
Manages staffing including interviewing, selecting, supervising, and ensuring policy compliance.
Determines job objectives, reviews performance, and administers personnel actions including salary changes, promotions, and discipline.
Promotes a culture of quality awareness and regulatory compliance understanding.
Oversees regulated activities meeting federal, state, and local regulations.
Enhances quality system elements through continuous improvement including QMS implementation and maintenance.
Manages regulatory strategy, inspection responses, and compliance with regulatory letters and observations.
Ensures contracted services comply with regulations to avoid service disruption.

Expectations:

Travel: 25%
Work Hours: 40-hour work week

Qualifications

Minimum Knowledge, Skills, and Abilities:

Bachelor's degree in Life Sciences or related field.
10+ years experience in Quality and Regulatory Compliance.
5+ years recent management experience in regulated healthcare environment with project management skills.
Experience managing Quality and Regulatory Compliance in pharmaceutical, medical device, biologics industries.
Track record implementing and managing quality standards.
Experience leading QA/RA teams for complex products.
Knowledge of all aspects of GXP regulations.
Ability to manage priorities and meet goals in fast-paced environments.
Two or more ASQ certifications.
Experience with Microsoft Office Suite (Word, Excel, PowerPoint).
Knowledge of continuous improvement tools such as Six Sigma or LEAN.
Strong communication skills and ability to motivate others.
Innovative with the ability to transform ideas into impactful solutions.
Highly principled with proven integrity and ethical standards.

Preferred Qualifications:

Master's degree in Life Sciences or related field.
5+ years recent management experience in distribution & logistics quality & regulations in regulated healthcare environment.
Federal and State licensure.
Experience with specialty, cold chain, controlled substances, biologics, and combo devices.
10+ years project management in quality & compliance oversight.
10+ years experience in data & analytics, trend analysis, and establishing KQIs.
Experience in life sciences service provider regulatory consulting.
Experience launching new functions/programs.
ASQ Management and Lead Auditor certifications.

Additional Information

Our Cultural Beliefs:

Patient Minded: Act with patient's best interest in mind.
Client Delight: Own every client experience and its impact on results.
Take Action: Empower self and others to act promptly.
Grow Talent: Own personal development and invest in others' development.
Win Together: Connect passionately to achieve results.
Communication Matters: Speak up for transparent and timely dialogue.
Embrace Diversity: Create an environment of awareness and respect.
Always Innovate: Be bold and creative in everything done.

Note on recruitment fraud and equal opportunity employment policies included. Diversity, Equity & Inclusion are key to success. Reasonable accommodations available upon request.