Geared toward candidates with pharmaceutical quality management experience comfortable with client liaison and continuous improvement activities.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Simtra BioPharma Solutions via Greenhouse
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 Manager I, Quality Client Services is the liaison between Simtra and clients in regards to quality-related activities. This role manages Quality Client Representatives who serve as primary Quality contacts with clients. This position reports to the Sr Manager of Quality Assurance Product Release and Quality Client Representation.
The responsibilities:
Manage Quality Client Representatives.
Manages client project quality updates and reviews with all levels of management.
Making accurate and timely quality decisions pertaining to client projects, questions, and quality requests.
Escalate quality issues to impacted departmental Quality Manager and/or Quality Director as necessary for corrective action implementation.
May oversee quality system, such as CAPA or NCR.
Partners with Quality leadership to sign off on applicable documentation that may include: validations, protocols, non-conformances, CAPA, and annual product reviews
Review and approve exception reports as needed to meet client delivery dates and expectations.
Represent Quality in required Project Client Meetings.
Track, trend, compile and report client quality metrics as necessary.
Negotiate and provide guidance in the approval process of Quality Agreements.
Lead continuous improvement activities to maximize business results.
Job requirements:
Bachelor’s Degree required, preferred science-related field.
Minimum 5 years experience in pharmaceutical and 1-2 years of supervisory experience.
Knowledge of quality operating procedures and quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
Project management and customer service experience required.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, 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 requires sitting for long hours but may involve walking or standing for periods 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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