Quality Systems Lead, Veeva

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.

 

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

 

 

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:

• Bachelor's degree required, preference in a Life Science field
• Minimum 7 years experience in Quality or equivalent pharmaceutical industry experience
• Minimum 3 years in a role providing project management disciplines
• Experience with Veeva software, preferably Quality Docs, Vault Training, QMS
• 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