Sr. Manager, Computer Systems Quality - Quality Assurance

Quality Assurance Hayward, California

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Description

The primary responsibility for this position is to support quality oversight of change control and validation activities as related to regulated computer systems for 21 CFR Part 11 compliance.  This individual will also work closely with internal stakeholders on improvement of Veeva platform systems for supporting various key quality processes such as internal/external audits, change control, deviation/CAPA, inspection management, product complaint, and supplier management. This is a key quality management role reporting to the Director of QMS, Quality Assurance.

Responsibilities

•          Partner with IT Compliance to provide quality risk assessment of regulated computer systems like SAS and Veeva platform systems such as Veeva Platform, Veeva Clinical (CTMS, eTMF), Veeva Quality (VVQD, VVT, QMS), Veeva RIMS (Submission), Biometric Programming Environment (BPE), Active Directory, Okta Single Sign on, Arcus Cohesity, Arcus MFT, DocuSign Part 11 and Arcus AWS Cloud for GxP purposes.

•          Provide quality evaluation of change controls affecting validated computer systems for GxP purposes.

•          Review and approve user requirements, functional specifications, IQ/OQ/PQ protocols and reports for validation of computer systems for GxP purposes

•          Develop, review, and approve pertinent SOPs and/or work instructions as needed to support implementation and reconfiguration of Veeva systems.

•          Develop, modify, and utilize tools to track and trend areas of deficiency and potential compliance issues as related to validated computer systems; monitor, communicate, and act on any emerging trends.

•          Coordinate and manage compliance related activities in preparation for regulatory agency inspection and support interactions during regulatory agency inspections, partners audit and customer audits as related to validated computer systems.

•          Be flexible and prepared to perform other related tasks as assigned.

 Qualifications

  • BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
  • 10+ years of biopharmaceutical industry experience with direct experience in Quality Assurance or similar compliance function
  • Experience with implementation and management of electronic quality management systems, experience with Veeva Vault is highly desired.
  • Strong knowledge of 21 CFR Part 11 regulations and GMP requirements for computerized systems
  • Working knowledge of US FDA, EU and ICH regulatory requirements and guidelines applicable to clinical research.
  • Working knowledge of GMP and ICH requirements and guidelines for manufacture of biologics or pharmaceuticals
  • Experience with internal/external audits, health authority inspections and inspection readiness activities preferred

Competencies:

  • Excellent verbal and written communication skills (e.g., listening skills, ability to interpret and summarize information and clear and concise communication skills)
  • Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
  • Strong interpersonal skills and the ability to assist personnel in a fast-paced environment and the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
  • Highly ethical, self-motivated and self-directed
  • Works effectively and independently as well as in a team environment.
  • Ability to effectively interacts with internal peers and site management to lead continuous improvement.
  • Demonstrate accountability in a fast-paced environment and work independently with high degree of flexibility.
  • Possess positive attitude, and strong interpersonal skills.
  • Ability to work effectively in a team environment with exceptional interpersonal skills, and attention to details.
  • A self-starter individual, highly motivated with high level of initiative and strategic planning
  • Provide clear direction to internal stakeholders.
  • Possess a leadership style and not a follower in a project setting and group meetings
  • Customer Service approach

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. 

This hybrid role will be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $160,000 - $175,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. 

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets 

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