Director of Quality

This role is to help support and oversee the quality group, with a focus on compliance and auditing to ensure alignment with pharmaceutical and medical device regulations.

• Work to handle inspection readiness, internal audit programs, external audits, compliance, customer complaints, and quality management reviews.
• Act as the process owner of quality events, deviations, non-conformance CAPA, change control, document control, and training.
• Support the development of quality systems and handle compliance surveillance.

Work Environment-This person will work 100% onsite with occasional work from home on Fridays due to the on-the-floor support and audit readiness team requirements.

The working environment is business casual, and the role operates during the first shift, Monday through Friday.

Day to day task

• Support and oversee the quality group with a focus on compliance and auditing.
• Ensure alignment with pharmaceutical and medical device regulations.
• Handle inspection readiness and internal audit programs.
• Manage external audits and compliance.
• Address customer complaints and conduct quality management reviews.
• Act as the process owner for quality events, deviations, non-conformance CAPA, change control, document control, and training.
• Support the development and implementation of quality systems.
• Handle compliance surveillance.
• Compliance
• Audit
• External audit
• Quality assurance
• CAPA
• Change control
• Document control
• Quality systems
• Customer complaints
• Regulatory
• Risk management

Bachelor’s degree in a related medical, science, or business discipline.

Minimum 15 years’ functional experience in Quality within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries.

Equivalent combination of education and experience.

Job Type: Full-time

Pay: $174,000.00 - $220,000.00 per year

Schedule:

• 8 hour shift

Work Location: In person

Salary : $174,000 - $220,000