Quality Client Representative

Simtra BioPharma Solutions; United States; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with Co

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Workout Facility

Cafeteria

Credit Union

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Quality Client Representative to manage all quality aspects of client projects, ensuring compliance and exemplary service from the core client team.

You will partner with cross-functional leaders to drive quality decisions, maintain documentation, and represent Quality in client meetings while supporting continuous improvement and regulatory alignment.

Qualifications

• Bachelor’s degree required, preferably in a science field with 5 years pharma industry experience or a Master’s with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
• Knowledge of worldwide regulatory requirements.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, Blue Mountain, Trackwise, etc.)

Responsibilities

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects, questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for corrective action implementation.
• Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents, as the Quality representative in a timely manner.
• Partners with Program Manager, Technical Services Representatives, Quality Control Representative and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information.
• Represents Quality in required Project Client Meetings.
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile, and report client quality metrics as necessary.
• Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product.
• Assist and lead quality agreement contract negotiations
• Identifies and leads continuous improvement activities to maximize business results.

Skills

quality liaison

project quality

regulatory knowledge

Education

Bachelor's degree (science preferred)

Master's degree (pharma preferred)

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

D365

Veeva

Blue Mountain

Trackwise

Job description

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.

The role:

The Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager.

The responsibilities:

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects,
• questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for
• corrective action implementation.
• Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents,
• as the Quality representative in a timely manner.
• Partners with Program Manager, Technical Services Representatives, Quality Control Representative and
• Manufacturing Representative to coordinate projects, provide support, align facility representation, and
• provide consistent quality information.
• Represents Quality in required Project Client Meetings.
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile,
• and report client quality metrics as necessary.
• Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master
• Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship
• and product.
• Assist and lead quality agreement contract negotiations
• Identifies and leads continuous improvement activities to maximize business results.

The requirements:

• Bachelor’s degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master’s degree with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical,
• biological and biochemical quality.
• Knowledge of worldwide regulatory requirements
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
• (examples include: D365, Veeva, Blue Mountain, Trackwise, etc.)

Physical / Safety Requirements:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours of time

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.

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