Quality Project Manager

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 Project Manager is responsible for managing major facility projects related to quality. The project manager provides leadership, oversight and decision making to meet deliverables and ensure compliance to applicable policies, procedures, and regulations for projects of responsibility. He or she must communicate effectively with internal team members, corporate team members, multiple levels of management, and external clients.

The responsibilities:

• Provide project management leadership of build back projects associated with quality systems
• Provide project management and planning for implementation of new eQMS (Veeva), which includes replacement of global quality IT systems such as Trackwise for NCR/CAPA/CCM/SQLM/Audit/Complaints, TcU, VDK, CFS, BAXU, etc.
• Ensure compliance with all applicable policies and regulatory requirements
• Ensure the appropriate level of integration between sites to efficiently meet customer and regulatory expectations.
• Provide support to key Global Quality projects like Quality Habits and Medicinal Minds Culture.
• Create an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
• 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.
• Ensuring compliance to plant procedures, corporate quality policies, Federal and Foreign country regulations and guidance’s.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions as necessary to meet plant and department goals/objectives.

Required 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
• 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, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Knowledge of quality operating procedures and quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.

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
  • Short and Long-Term Disability 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
• Additional Benefits
  • 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 12/31/24

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.
                                                                                                                                                            
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