What You'll DoAs a key member of the Quality team, you will oversee core quality system processes including CAPA, change management, customer complaints, product release, internal auditing, document control, and regulatory readiness. You will play an important role in ensuring compliance with FDA regulations, customer requirements, and internal quality standards while helping drive continuous improvement across the facility.
Quality Systems Leadership- Develop and manage deviation, non-conformance, investigation, and CAPA processes.
- Lead and maintain the site's Change Management program.
- Oversee customer complaint management, including investigations, trend analysis, reporting, and corrective actions.
- Manage product release activities, batch record review processes, quality metrics, and customer Certificates of Analysis (CoAs).
- Coordinate Annual Product Reviews and Quarterly Management Reviews.
- Administer the Document Control program, including change control activities and system metrics.
- Lead the Internal Auditing program, including auditor training, audit execution, system development, and reporting.
Regulatory Compliance & Continuous Improvement- Partner closely with Quality Operations, Quality Laboratory, and Manufacturing teams to ensure effective and compliant quality systems.
- Serve as a key participant during FDA inspections, customer audits, and third-party regulatory audits.
- Manage GMP and sanitation programs and improvement initiatives.
- Drive a culture of quality, compliance, and operational excellence throughout the organization.
Team Leadership- Develop, coach, and manage direct reports.
- Foster collaboration and accountability while supporting Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.
What We're Looking ForRequired Qualifications- Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or a related scientific discipline.
- Minimum of seven years of experience supporting quality assurance systems within pharmaceutical, medical device, or other FDA-regulated manufacturing environments.
- Minimum of three years of leadership experience or experience serving in an advisory capacity.
- Five or more years of experience interacting with regulatory agencies or regulatory bodies, such as the FDA or TGA.
- Demonstrated experience with:
- Root cause analysis
- Risk analysis methodologies
- CAPA management
- Regulatory investigations
- Internal and external audits
- Document control systems
- Change management
- Complaint management
- Deviation and non-conformance programs
Preferred Qualifications- Advanced degree in a scientific or related discipline.
Benefits That Support YouWe offer a comprehensive benefits package designed to support your health, financial security, and work-life balance, including:
Health & Wellness:- Medical, dental, and vision coverage
- Wellness programs
- Fitness reimbursement
Financial Security- Retirement savings plan with company match
- Life and disability insurance
- Optional supplemental coverage
Career & Lifestyle- Paid time off starting on your first day
- Education reimbursement
- Employee discount programs
Mental Health Support- Confidential counseling and resources for personal and work-life needs
