Biibhr
Sr. Associate III, Compliance - QRM Lead
Research Triangle Park, NC · Senior
Sponsorship not specified$111k-$149kDetected 26 days ago
Stakeholder ManagementGMPFDA RegulatoryLeadershipCommunication
About the role
- This role is responsible for ensuring the site always remains in a state of control and inspection-ready, supporting both domestic and international regulatory expectations.
Responsibilities
- Lead and manage the site Quality Risk Management (QRM) program, ensuring alignment with global policies and site procedures
- Maintain and oversee QRM repositories and lifecycle management within the Quality Management System
- Drive inspection management activities including scheduling, execution, response coordination, and regulatory requests
- Lead implementation and continuous improvement of risk management practices across the site
- Collaborate cross-functionally to support compliance, data integrity, and quality initiatives
- Support development of QRM training and enable risk facilitators across the organization
- Use data and established KPIs to monitor compliance and drive continuous improvement
Requirements
- You are a quality and compliance leader with strong expertise in risk management and a passion for driving continuous improvement in regulated manufacturing environments.
- Bachelor's degree in scientific, technical, or relevant discipline
- At minimum 6 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments
- Strong knowledge of cGMP regulations and global regulatory standards (e.g., FDA 21 CFR 210/211, ICH Q9)
- Experience with quality systems including risk management, change control, deviation management, and inspection readiness
- Master's degree (MBA, MS, or similar) with relevant experience
- Experience leading site-wide or global quality risk management programs
- Advanced knowledge of quality metrics and data-driven decision making
Nice to have
- Preferred skills
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid Maternity and Parental Leave benefit
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- We are a global team with a commitment to excellence, and a pioneering spirit.
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biibhr's careers page and normalized into a canonical job model.