What are the responsibilities and job description for the Director of Quality Assurance position at Actalent Services?
Job Description
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.
Responsibilities
- 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.
Essential Skills
- Compliance
- Audit
- External audit
- Quality assurance
- CAPA
- Change control
- Document control
- Quality systems
- Customer complaints
- Regulatory
- Risk management
- Reporting
Additional Skills & Qualifications
- 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.
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.
Job Types: Full-time, Permanent
Pay: $175,000.00 - $224,000.00 per year
Schedule:
- 8 hour shift
Work Location: In person
Salary : $175,000 - $224,000
