Location: Ambler, PA
Gyroscope: Vision for Life
Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.
To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.
Quality Assurance Manager:
The QA Manager role will be critical in supporting Gyroscope’s Quality Management System. Reporting to the Head of QA, the QA manager will be responsible for supporting QA activities such as Document Control and Training Management and developing modules for QMS critical activities (e.g. Supplier and Vendor Qualification, Auditing, Change Management, etc.
The incumbent must possess extensive knowledge of , as well as excellent time management and interpersonal skills. This role will closely interact with all staff members across the organization in a collaborative way. Responsibilities include, but are not limited to:
Leading and managing QA’s day-to-day activities in support of Gyroscope’s QMS, with focus on the development, deployment, and management of the eQMS system (e.g., Document Management, Training, Supplier and Vendor Qualification, Auditing, etc).
Serving as the system’s SME and main Point of Contact to answer questions, troubleshoot, and provide training to staff on the eQMS system’s platform.
Lead as Training Coordinator for the whole organization, which will include managing new hire onboarding, assigning training requirements for all staff, and ensuring training curricula is kept compliant, etc.
Work with management to ensure all staff is compliant with their training files. Coordinate and facilitate the timely completion of the annual review of the training files.
Execution of the Document Retention policy, which includes sorting, organizing, and archiving GxP documents, either on paper or electronically.
Maintain applicable document trackers up-to-date.
Responsible for Document Control activities, including facilitating the creation and review of controlled documents (SOPs, Instructions, Forms, etc)
Management of the SharePoint Quality Site.
Additional responsibilities will include:
Managing the internal audit schedule. This includes generation of reports and CAPAs, and following up on all action items to ensure their timely closure.
Development, implement, and report applicable quality metrics and KPIs.
Work closely with the Head of QA to help identify areas of improvement. This may include review of SOPs and procedures, conducting gap assessments, etc.
Qualifications and Experience:
A minimum of a Bachelor’s degree in Chemistry, Pharmacy, Biochemistry or related discipline is required. Experience will be considered in lieu of a degree.
A minimum of 8 years of QA cGMP experience in biotech/pharma
GCP and GLP experience is preferred.
Gene Therapy experience is a plus.
Excellent communication and problem-solving skills.
Ability to work independently and with minimal supervision is required.
Strong computer skills with Word and Excel; experience with eQMS is preferred.
Experience or familiarity with eQMS providers such as Veeva, MasterControl, ComplianceWire, etc.
Ability to work effectively at a fast-paced environment with cross functional departments. This role requires the incumbent to be able to quickly adapt to changing priorities.
Past experience managing complex projects is required.
Ability to identify areas of improvement and provide solutions. Excellent technical writing and problem-solving skills.
Some international travel may be required (up to 20%).