Director of Quality Operations

SaniSure LLC•Camarillo, CA

5d•$170,000 - $190,000

About The Position

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

Requirements

Bachelor’s degree in Quality Management, Engineering, or a related field; Master’s degree preferred.
5+ years of experience in quality management or a similar role.
Strong knowledge of quality assurance methodologies (e.g., Six Sigma, ISO 9001, ISO 13485).
Must have 3+ years of recent experience in pharmaceutical, biopharma, or medical device industries.
Excellent analytical and problem-solving skills.
Solid background in quality assurance, regulatory compliance, and process improvement.
Strong communication and leadership abilities.
Proficient in quality management software and tools.
Certification in Quality Management (e.g., CQE, CQM).
Skilled professional able to lead and motivate a team, manage performance, and resolve conflicts.
Excellent verbal and written communication skills.
Able to manage multiple priorities and meet deadlines.
Competent in interpreting data, generating reports, and making data-driven decisions.
Proactive approach to identifying opportunities for improvement and driving positive change.

Nice To Haves

Master’s degree preferred.

Responsibilities

Ensure that facilities, equipment, materials, organization, processes, procedures, and products align with ISO 9001, ISO 13485, and applicable standards.
Lead the quality assurance processes across different regions and product lines, ensuring products meet quality standards.
Provide oversight to disposition of high-risk product nonconformances; assure adequate technical investigations and appropriate corrective actions are in place to prevent reoccurrence.
Develop, implement, and maintain quality management systems and policies.
Support internal audits and certification audits at SaniSure and its suppliers.
Provide leadership to the Quality team to proactively identify quality signals and trends and drive actions needed to mitigate adverse quality trends.
Train and mentor quality personnel on quality control processes and best practices.
Ensure appropriate staff development and training in areas of responsibility.
Ensure documentation of quality processes follows industry standards.
Stay updated on industry regulations and changes in quality standards.
Set and track department goals and objectives in alignment with company goals.
Identify areas for cost reduction and increased efficiency.
Address employee concerns and resolve conflicts; coordinate with Human Resources as needed.
Collaborate cross-functionally and across the SaniSure organization to ensure Quality Management System processes are implemented, maintained, and performed in accordance with established procedures and applicable standards.
Champion, maintain, and support continuous improvement to the product QMS; monitor and identify areas for improvement and ensure remediation.
Support development and management of Quality Agreements, external audits of suppliers, and third parties with Supply Chain.
Ensure team members adhere to company policies and procedures including PPE and ISO regulations.
Perform other duties as assigned.