Associate Director, Quality Systems

Required experience & skills:

• Bachelor’s degree in life science, quality, engineering, or related discipline.
• Minimum of 10 years of progressive pharmaceutical or biotechnology quality experience, with substantial direct experience managing quality management systems.
• Demonstrated hands-on experience with electronic QMS administration, document and records management, GxP training, change control, deviations, CAPA, and other core QMS processes.
• Demonstrated knowledge and practical application of ISO 9001 principles and quality management system requirements.
• In-depth understanding of controlled documents and GxP record types, metadata, classification, retention, lifecycle management, and retrieval.
• Demonstrated experience developing and maintaining role-based training matrices and administering GxP training programs.
• Strong working knowledge of GxP principles, with sufficient GMP experience to understand and manage documentation and records across pharmaceutical development.
• Strong attention to detail and demonstrated ability to establish and maintain logical, consistent document, record, metadata, and training structures.
• Excellent organizational, problem-solving, prioritization, and time-management skills
• Ability to independently manage multiple quality systems activities and work effectively across functional teams.
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills:

• Experience working in a small, growing, or startup pharmaceutical or biotechnology organization
• Experience developing or expanding a quality management system in a growing organization
• Experience with QMS metrics, trending, management review, process improvement, continuous improvement, and operational excellence
• Lean Six Sigma Green Belt or Black Belt certification
• Experience supporting regulatory inspections and GxP audits
• Experience with computerized system validation and oversight of GxP computerized systems
• Experience supporting late-stage development and transition toward commercial operations

Base Salary Range: $170k - $200k

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

Braveheart participates in the federal E ‑ Verify program to confirm employment authorization for all new hires.

To learn more about E-Verify please review this poster .