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
DisclaimerThis 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.
