Director of Quality

We are seeking a highly motivated and experienced Director of Quality. This key position will lead the QA/QC function for diagnostics and therapeutic programs, which are currently in early-stage development.

Principal Responsibilities:

• Assure quality products and processes by establishing and maintaining quality standards within the Quality Management System.
• Author quality assurance procedures to conform to company and industry requirements.
• Manage the implementation, maintenance, and improvement of Quality Systems based on established company direction, development phase, and priorities.
• Lead and perform activities related to: Quality Management Reviews, Internal Audits, Supplier Audits, CAPAs, Deviations, Training, Document Control, Change Control, and Risk Management.
• Compile and report performance indicators, metrics and compliance status of Quality Systems.
• Establish and maintain continuous improvement programs.
• Assist with training on GxP and other quality-related topics.
• Represent Quality Department during regulatory inspections, as needed
• Drive strategic decisions, implement processes and manage activities related to QC systems. Build roadmap for the QC function through sound scientific and regulatory knowledge and experience.
• Work cross-functionally with internal and/or external partners (i.e. CDMOs) to write technical documentation for incoming materials, in-process and finished products, and post-launch monitoring. 
• Oversee stability studies and shelf-life programs including authoring shelf-life reports.
• Serve as QC Subject Matter Expert (SME) for analytical methods, sampling, troubleshooting, investigations, deviations, non-conformances, etc.
• Work with other SMEs (internal and/or external) to review and author application sections of regulatory submissions, and to provide support for information requests, as required.

Education and Experience:

• Masters (PhD preferred) in chemistry, biochemistry, pharmaceutical sciences, bioengineering, or related discipline At least 5 years quality management experience and 10+ years industry experience in analytical development and/or quality (CDMO and/or IVD experience preferred)
• Demonstrated knowledge of regulations related to diagnostics and preferably therapeutics (i.e. GxP, ISO 13585, 21 CRF Part 820, etc.), experience with FDA filings preferred
• In depth knowledge of therapeutics and/or diagnostics raw material release and stability testing, methods, and quality systems.
• Experience establishing and/or managing QMS and quality assurance programs

Required Skills and Abilities:

• Excellent written, verbal, and interpersonal communication skills with demonstrated ability to write and summarize quality information, reports, and processes.
• Competency with electronic quality managements systems
• Ability to work cross-functionally, both internally and externally, to advance company goals and initiatives.
• Strong technical acumen, including proficiency at determining the root cause of a problem, and working with others to implement solutions.
• Comfortable in a fast-paced small company environment and able to balance workload based upon changing priorities.