Manager/Sr. Manager of Quality Management Systems (QMS)

Manager/Sr. Manager of Quality Systems Management

Salary: $150-165k base (Depending on experience) plus bonus

Location: Remote

Therapeutic Area: Oncology and Rare Disease

We are partnered with a growing, commercial-stage biotech organization focused on advancing innovative therapies across multiple indications who is searching for a Manager, Quality Management Systems, who is responsible for supporting the Veeva documentation, learning management systems and supplier quality management as needed.

The successful candidate is proficient in communication (written and verbal), is action-oriented and timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company that is transitioning to the commercial phase.

Responsibilities

• Support of the Veeva Quality Management System administration, including processing of documentation, training and quality system processes.
• Support the administration and maintenance of electronic and physical record documentation processes and systems, including:
• Support of Veeva development of procedures, work instructions, physical record documentation system processes, including physical record distribution, archival, retention and destruction.
• Function as a Veeva Document Management System Subject Matter Expert; provide support and guidance to internal customers and expertise on document technical writing and effective document content and design to authors, conduct end-user electronic system training, and processing of documents through the Veeva system.
• Support document coordinator related activities, as needed, including, but not limited to performing document control review/approval on documentation managed through the electronic document management system, distributing official documents to internal and external customers, monitoring and executing the document periodic review process.
  
  

• Support the administration and maintenance of training management processes and systems, including:
• Support training related activities, as needed, including, but not limited to receiving and processing training requests, creation and modification of training profiles, training curriculums, training plans and training user groups, execution of periodic and annual training review processes, and identification of document training needs.
• Report training information to internal and external customers, auditors and/or inspectors upon request.
• Support system administration activities for electronic Veeva Document Management and Learning Management Systems.
• Support the management of the supplier management program, including:
• Review of routing of supplier quality agreements.

Requirements

• Bachelor’s Degree (BA/BS) with a minimum of 7 years of experience in a GMP regulate
• Biologics or Pharmaceutical environment
• Knowledge and understanding of Quality Management System regulations and requirements, global quality standards and cGMPs relating to documentation, training and electronic systems, including electronic records and signatures.
• Strong authorship and ability to communicate effectively across the entire organization on matters related to documentation and training management systems. Able to prepare written communications with clarity and accuracy.
• Must be able to work independently with the ability to complete routine tasks with little or no supervision.
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner, adaptable to dynamic conditions, work practices, and project timelines.
• Must be proficient in Veeva. Microsoft Office (e.g. Excel, Word, Access, Power Point, Visio) and Adobe Professional software.
  
  

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation.

Email tom@scientificsearch.com or message me directly if you’d like to learn more.