Engineering for new heights in the treatment of inflammatory bowel disease

Manager, Quality Systems

ManagerManagerFull TimeRemoteTeam 11-50H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

33 days ago

Salary

$140K - $151K / year

Bachelor Degree5 yrs expEnglishVault

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

Job 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.