Quality, Assurance Manager
Department: Quality Assurance
Reports to: Director, Quality Assurance
Location: Framingham, MA Office (US-based )
Summary of job description:
Ensures the administration of the quality and GxP process efforts of the Replimune Framingham facility. Work with cross functional teams to maintain and present the internal quality systems associated with GxP activities to ensure the successful and timely release of drug product and clinical trial material by providing quality oversight of the overall manufacturing, testing, packaging and labeling processes. Supervises and guides inspectors, technicians/associates and other staff.
- Consistently perform duties within established SOPs and in accordance with GxP
- Review and approve Standard Operating Procedures (SOPs), Nonconformances, Change Controls, Validation Protocols/Reports, Batch Records and Engineering Drawings, ensuring internal and external standards are met.
- Develop strong internal collaboration with stakeholders such as Clinical Operations, Regulatory Affairs, and Manufacturing functions to ensure continuous communication of quality topics.
- Participate in audits and risk assessments.
- Work with all departments on the closure and content of investigations. This includes all types of investigations; out of specifications (OOS, Chemical and Microbiological), Manufacturing, Engineering, Technical Services, etc.
- Provide QA input and approvals to projects as needed.
- Establish, collect and report quality metrics.
- Provide oversight of assigned staff members including scheduling, training, and development opportunities.
- Conduct training as needed (inspection readiness, risk assessment methodology, etc.).
- Promote GxP and Quality mindset at all levels within the organization.
- Performs other related duties and ad hoc projects as required by position.
- BA or BS in a Science or Logistics field or equivalent experience in the Quality function.
Experience and skill requirements:
- 10+ years of experience working in the biopharmaceutical industry.
- 5-7 years of quality assurance experience required.
- Proficiency in MS Word, Excel and PowerPoint.
- Knowledgeable of regulations and requirements of GMPs for biologics manufacture.
- Ability to work independently on projects within a team-oriented environment.
- Innovative thinker with ability to solve complex problems.
- Adaptable, flexible, and able to manage change.
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.