Manager, Quality Systems
Job Description:
• Manage and maintain a compliant Document Control System (Veeva)
• Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product quality related documents) and archiving activities.
• Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for each function and reporting monthly metrics.
• Manage the processing of QMS items for Change Control, Deviations and CAPAs
• Generate Quality System metrics as per established timelines and assist in generating data for Quality Management Reviews.
• Work with document authors and reviewers to process documents.
• Oversee periodic document review process to ensure compliance with established review schedules.
• Onboarding/Offboarding employees and assigning training.
• Train and mentor users on the use of eQMS, process and procedures.
• Support Spyre functional groups as needed.
• Other duties as assigned
Requirements:
• Bachelor’s degree in life sciences or a related field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality control/quality assurance functions. A combination of relevant education and experience may be considered.
• Experience with monoclonal antibodies is preferred.
• In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits.
• Experience in the use of Veeva electronic quality management systems (eQMS) (Veeva Vault or Veeva Quality Basics) required.
• Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously.
• Strong verbal / written communication and presentation skills with the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts including contract service providers, strategic partners, and regulatory organizations.
• Demonstrated ability to work in a fluid, dynamic and fast-paced environment.
• Proficient in Microsoft suite products; Microsoft Word, Excel, PowerPoint, Outlook.
Benefits:
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Apply Now
Apply Now
• Manage and maintain a compliant Document Control System (Veeva)
• Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product quality related documents) and archiving activities.
• Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for each function and reporting monthly metrics.
• Manage the processing of QMS items for Change Control, Deviations and CAPAs
• Generate Quality System metrics as per established timelines and assist in generating data for Quality Management Reviews.
• Work with document authors and reviewers to process documents.
• Oversee periodic document review process to ensure compliance with established review schedules.
• Onboarding/Offboarding employees and assigning training.
• Train and mentor users on the use of eQMS, process and procedures.
• Support Spyre functional groups as needed.
• Other duties as assigned
Requirements:
• Bachelor’s degree in life sciences or a related field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality control/quality assurance functions. A combination of relevant education and experience may be considered.
• Experience with monoclonal antibodies is preferred.
• In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits.
• Experience in the use of Veeva electronic quality management systems (eQMS) (Veeva Vault or Veeva Quality Basics) required.
• Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously.
• Strong verbal / written communication and presentation skills with the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts including contract service providers, strategic partners, and regulatory organizations.
• Demonstrated ability to work in a fluid, dynamic and fast-paced environment.
• Proficient in Microsoft suite products; Microsoft Word, Excel, PowerPoint, Outlook.
Benefits:
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Apply Now
Apply Now