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Senior Manager GLP/GCP Veeva Doc Control and Training

Sana Biotechnology

Sana Biotechnology

San Francisco, CA, USA · Cambridge, MA, USA · United States · Remote
Posted on Wednesday, June 19, 2024

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Sr Manager Veeva Doc Control and Training you will report to the Executive Director Global GCP/GLP and QA. This person will be responsible for formatting, review, issuance, and control of procedures, work instructions, forms, and test methods throughout the organization. The Sr. Manager will also help maintain all employees' training files and curriculum, to ensure employees remain current in assigned training.

What you’ll do

  • Responsible for the end-to-end lifecycle of documents in Veeva.
  • Provide customer support to authors and approvers regarding creation, reviewing, revising, and obsoleting procedural documents.
  • Advise cross functionally to identify document type, impacted stakeholders, and review cycle including conflict resolution and approval.
  • Identify (with stakeholders) document changes that impact regulations and escalate to appropriate owner or quality assurance.
  • Work with cross functional teams to set up Learner Roles and Curricula and add to Veeva
  • Upload training materials
  • Ensure training requirements are identified and implemented.
  • Provide training status companywide and escalate risk and issues
  • Perform administrative activities for Quality Docs and Training as the administrative user role
  • Perform bulk upload of legacy documents
  • Reformat documents and configure tokens fit for Veeva
  • Create templates for fillable forms for Veeva

What we’re looking for

  • Bachelor’s degree in Chemistry or Biological Science
  • 8+ years’ experience in biopharmaceutical industry
  • Knowledge of QA systems and GCP/GLP compliance requirements
  • Proven track record working in a multi-functional team environment
  • Prior Veeva QualityDocs and/or Training implementation experience or administrator role
  • Strong oral and written communication skills needed
  • Excellent interpersonal skills to engage client groups and problem solve

What will separate you from the crowd

  • Familiar with US FDA, EMA, and ICH regulations and guidelines

What you should know

  • The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together for patients

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.