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Associate Manager, Process Development in Irvine, CA at Apex Life Sciences

Date Posted: 11/20/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/20/2018
  • Job ID:
    916082

Job Description


Summary:

  • The Associate Manager Process Development partners with functional representatives in R&D to manage the development, workflow and implementation of R&D processes as well as requests during audits and health authority inspections.
  • This position is office based. 

Deliverables include:

  • Support the R&D Quality Management System by: 
    • Collaborating globally with functional process owners within R&D to drive the development, revision, implementation and retirement of R&D processes, 
    • Driving the review and approval workflow and function as an administrator within the document development and management systems. 
    • Ensuring alignment with regulations and company policies and consistency across processes, 
    • Identifying process-related issues and support process improvements, 
    • Supporting the preparation and conduct of audits and health authority inspections. 
    • Regularly update industry and company specific knowledge and continuously improve skills related to the development, documentation and management of processes. 
  • Other activities, special projects and assignments may be given as required.
  • As a result the percentage of time spent across roles for which the position is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole. 
  • The associate must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 

Key duties and responsibilities: 

  • Manage the development and workflow of process documents 
  • Process mapping experience required 
  • Collaborate globally with functional area process owners within R&D to drive the development, revision, implementation or retirement of processes, and to identify SMEs/authors, reviewers, and approvers. 
  • Facilitate stakeholder meetings, map business processes, and gain consensus on content within new and revised processes.
  • Collaborate with document authors on the review of process documents and perform quality checks for alignment with regulations and policies, format, internal and end-to-end process consistency. 
  • Drive the official review and approval workflow, function as an administrator within the document management system and the QMS; and contribute to the development or revision of existing systems. 
  • Collaborate and coordinate with the Training Team for the roll-out and implementation of process documents. 
  • Author and maintain process documents and other associated documents as required. 
  • Drive the development and maintenance of a glossary of terms for R&D. 
  • Ensure consistency across processes, identify process-related issues, and support process improvements. 
  • Collaborate with corporate and R&D Quality Assurance to ensure alignment and information sharing. 
  • Stay current with best practices and regulations affecting the management and development of process and process management systems. 
  • Manage multiple priorities in various degrees of completion. 
  • Manage assigned tasks according to agreed-upon timelines. 
  • Engage Quality Assurance, Training and IT support as needed. 
  • Provide regular written and verbal reports around process development status. 
  • Communicate effectively and openly at all levels. 
  • In addition, the associate maintains key contacts within and outside of R&D including Biologics, Clinical Development, Device, Drug Development Operations, Medical Affairs, Non-Clinical and Translational Sciences, Pharmaceutical Development, Pharmaceutical Sciences Strategy, Project Management & Planning, Quality Assurance, Regulatory Affairs & Medical Writing, Research and Scientific Innovation, and Safety.
  • External interfaces include: industry groups, various contract research organizations and other vendors or consultants. 

Minimum Requirements: 

  • B.A/B.S. with 6 years of experience in research and development; MS/MA in related field may substitute for 1 year of experience. 
  • At least 2 years at advanced management and operations levels. 
  • At least 3 years directly related to management of systems and processes in a regulated environment. 

Knowledge: 

  • Excellent knowledge of GxP, ICH guidelines, PhRMA code, FDA CFR, ISO clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations. 
  • Proficient with electronic document management systems (EDMS) and business process mapping systems (e.g. Nimbus, TaskMap). 
  • Proficient with processes required for the creation of robust processes and procedures. 
  • Knowledge of clinical study operations and the drug development process 
  • Knowledge of concepts of clinical research and drug development 
  • Proficient with electronic systems including, Visio, Microsoft Office Suite, SharePoint, WebEx 

Competencies: 

  • Ability to handle and prioritize multiple priorities 
  • Self-starter with ability to work independently at the regional or global level with remote or minimal supervision 
  • Ability to work effectively in a team/matrix environment 
  • Ability to influence others without direct reporting relationships 
  • Ability to understand technical, scientific and medical information 
  • Demonstrated strengths in customer service, planning, organizational, project management and analytical skills, oral and written communication, time management, negotiation, conflict management and resolution, attention to detail, interpersonal and networking skills, relationship building, cross-cultural sensitivity

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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