United States onlySimtra 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.
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 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.
At Simtra, we recognize that attracting the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure we are able to attract the best candidates.
The pay range reflected represents what we reasonably expect to pay for this job. The pay offered will depend on factors such as the candidate’s education, experience, skills, and geographical location. In addition to base pay, employees are eligible to participate in an annual bonus plan and employee ownership plan. Eligible employees also receive a comprehensive and highly competitive benefits package, including a variety of health, retirement, caregiving, emotional wellbeing, and other flexible benefits—plus elective options to support the diverse needs of our workforce.
Salary Range: $104,000-$143,000
In return, you’ll be eligible for[1]:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
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