Quality Systems Lead, Veeva

BioBioPharma Tech Solutions

Veeva implementations

This role:

The Quality Systems Lead is responsible for managing Veeva Vault Workstreams on a global level. The Quality Systems Lead is a member of the Global team providing leadership, oversight and decision making to meet deliverables and ensure compliance to applicable policies, procedures, and regulations for projects of responsibility. The Quality Systems Lead must communicate effectively with internal team members, corporate team members, multiple levels of management, and external clients.

The responsibilities:

• Provide project management leadership for Veeva QMS Workstreams (Quality Docs, Vault Training, QMS, Validation, etc)
• Responsible for creating reports, monitoring and maintaining system compliance, creating and owning governing procedures, managing new release activities, supporting validation and configuration activities
• Responsible for providing guidance and support for site requests and issue resolution. 
• Support site regulatory inspection requests.
• Serve as Business Administrator for Veeva eQMS
• Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams
• Work with IT departments for integrations when data is shared cross-functionally
• Ensure compliance with all applicable policies, procedures, and regulatory requirements
• Ensure the appropriate level of harmonization between sites to efficiently meet customer and regulatory expectations.
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Regularly interact with senior management or executive levels on key quality projects
• Interface with the staff/customers to ensure Simtra quality commitments are met.
• Facilitate an environment of teamwork and communication between cross-functional departments and sites to meet Company goals/objectives.

Desired qualifications:

• Must be a Certified Veeva Platform administrator, Quality Docs, Vault Training, QMS
• Bachelor's degree required, preference in a Life Science field
• Must have experience in Quality or equivalent pharmaceutical industry experience
• Knowledge of GxP regulations, with prior experience supporting GMP operations (e.g. reviewing batch records, managing quality events)
• Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams
• Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization
• Strong analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner
• Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement
• Computer proficiency in Microsoft Word, Excel, Outlook, Visio, Project etc.
• Knowledge of quality operating procedures and quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.

Open to working in USA, Japan, and Germany time zones.