Quality Systems Lead, Veeva (Remote)

Simtra BioPharma Solutions

14d•$104,000 - $143,000•Remote

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. The Quality Systems Lead is responsible for managing electronic Quality Management System 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.

Requirements

Bachelor's degree in Life Sciences, Engineering, or related field
7 years experience in Quality / equivalent pharmaceutical industry experience
Served in a role providing project management disciplines with proven experience for implementation and maintenance of electronic Quality Management software, PMP preferred.
Experience with Veeva software, Quality Docs, Vault Training, QMS, Controlled Print
Knowledge of GxP / CSV regulations
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.

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.