What are the responsibilities and job description for the Director of Quality Assurance position at Ancillare?
Job Purpose:
The Director, Quality Assurance develops, implements and evaluates Quality System management strategies which integrate with company annual and long term global strategies. Ensures sites are regulatory and customer inspection ready at all times. Delivers a positive quality experience at all levels of the company.
Duties and Responsibilities:
- Develop, review, revise, distribute and train Standard Operating Procedures (SOPs) and associated documents.
- Manage and maintain training files ensuring that accurate, complete and up to date files are maintained for all employees and contract workers.
- Conduct and or direct investigations and implement corrective actions to resolve complaints and non-compliances. Evaluate the quality of events, incidents, queries and complaints.
- Ensure the consistency of creating, review or updating of internal/external deviations. Maintain current files for all recorded deviations.
- Partner with and effectively influence operations coworkers and colleagues to embed procedural compliance and quality into daily transactional activities, ensuring all processes contributing to the performance of company activities are conducted properly.
- Oversee and manage the change control system including documentation and filing as may be required.
- Facilitate and or perform internal, vendor and customer audits.
- Perform and document external audits of suppliers.
- Plan, coordinate and manage the recall process.
- Develop and implement training for employees on compliance with Quality System standards improving worker performance, knowledge of and support of a quality focused job.
- In collaboration with senior leadership strategize quality improvements to increase quality levels, ensure safety, reduce waste and increase profitability. Deploy quality improvements driving increased awareness and measure milestone results.
- Develop, maintain and provide to senior leadership realistic and meaningful quality metrics to drive continuous improvements.
- Develop and maintain supplier and customer Quality Agreements.
- Oversee supplier approval process.
- Develop and deploy Training Matrixes for new and transferred employees.
- Hire, train, supervise and mentor global quality staff.
- International travel as may be required.
- Other duties as may be assigned.
Qualifications:
- BS/BA degree required preferably in Life Sciences or engineering, may consider equivalent work experience in a CRO or comparable environment.
- 7 years’ experience in quality assurance within a contract research organization or comparable environment.
- Previous experience with contract packaging or ancillary support highly desirable.
Job Type: Full-time
Pay: $110,000.00 - $170,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: Hybrid remote in Horsham, PA 19044
Salary : $110,000 - $170,000
