Quality Systems Manager
Watertown, MA /
Are you interested in an engaging job and making a big impact in patient's lives?
Windgap Medical, Inc. is a rapidly growing, private company developing injection devices for self-administration of pharmaceutical compounds. Windgap’s first product is a wet/dry autoinjector for the delivery of epinephrine for the treatment of anaphylactic shock. Long-term, Windgap is leveraging its injectable platform and IP for other indications beyond epinephrine.
As the Quality Systems Manager, you will be responsible for the creation and maintenance of key Quality Management systems including Training, Supplier Management, Deviations, Investigations, CAPAs, Change Controls, Risk Management and Auditing/Inspections. In this position, you will ensure compliance with applicable regulations in support of GxP compliant programs, QSR and cGMP manufacturing and CMC activities. You will drive critical processes, initiatives and strategy for the QS department. The Quality Systems Manager will work with the Quality Engineering Manager to ensure that all aspects of quality are appropriately specified, executed upon, and documented, consistent with best practices.
The candidate will:
- promote and uphold a culture of quality, customer focus and operational excellence
- build and manage the quality systems around quality events including deviations, investigations, CAPAs, laboratory investigations, etc.
- manage and write/enable quality management procedures, system processes, work instructions and forms
- manage and deepen the quality supplier management processes including supplier qualification, approved supplier list, quality agreements, supplier change notifications, auditing and supplier corrective action requests, etc.
- manage and, where necessary, build quality system components and tracking systems which include the processing and circulation of SOPs, protocols, data reports, etc. for review and approval
- conduct risk assessments to support quality management systems and document justification for quality related decisions
- maintain and improve a regulatorily compliant Training Program
- oversee change management to support GxP activities
- lead and/or participate in internal audits as needed to support GxP activities
- provide oversight of validation and qualification activities for equipment, analytical instruments and computer systems
- direct data integrity remediation activities
- create and manage metrics to support trending and management review
- support internal, regulatory, customer and third-party audits
- manage projects in a cross functional environment that drives quality compliance and continuous improvement
- mentor less experienced personnel to support development and growth of junior staff
- serve as Management Representative
- report to the Company CEO
- Minimum of a four-year technical degree or equivalent education and work experience
- Demonstrable experience in pharmaceutical, biotech, medical device or related health-care industry
- Minimum of five years’ experience in QA Compliance with a proven track record of managing quality
- Hands-on experience with implementation of 21 CFR 210, 21 CFR 211, 21 CFR 820 and 21 CFR 4 within an organization
- Working knowledge of ISO 13485 and ISO 14971
- Attention to detail, time management, and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines with minimal oversight
- Strong interpersonal communication and soft skills, ability to work in team environment, and strong organizational / basic project management skills
- Experience in a start-up environment, requiring flexibility along with the ability to seek out and quickly assimilate new information
- Experience in interfacing with large pharmaceutical and medical device companies
- Operational experience with software-based quality and regulatory systems, preferably MasterControl
- Preferably, project management and costing expertise
- Preferably experience with statistical analysis and statistical tools such as Minitab, SPSS, Statistica, or JMP
- Ideally, previously been involved with internal regulatory audits for drug or device manufacturers
- Experience with MSOffice, including email, word processing, spreadsheets and presentation tools
Windgap Medical, Inc. offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.
The Windgap Medical Team