Quality Client Services Manager
Simtra BioPharma Solutions
Summary
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.
Job description
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.
Requirements
- Bachelor's Degree required, preferred science-related field
- Minimum 5 years experience in pharmaceutical
- 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
- Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, etc.)
Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Matching
- Paid Holidays
- Paid Time Off
- Paid Parental Leave
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Short and Long-Term Disability Insurance
- Vision Coverage
- Accident Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal Benefits
- Onsite Workout Facility
- Onsite Cafeteria
- Onsite Credit Union
Company overview
Simtra BioPharma Solutions is a premier, independently owned Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectable medicines. With over 65 years of manufacturing experience, the company offers world-class cGMP sterile fill/finish services, technical expertise, and quality solutions for pharmaceutical and biotech clients. Headquartered in Parsippany, New Jersey, with additional facilities in Bloomington, Indiana and Halle, Germany, Simtra provides comprehensive development and manufacturing services for parenteral products including prefilled syringes and vials. The company serves clients facing formulation challenges, clinical supply hurdles, market demand fluctuations, or risk mitigation concerns, offering tailored solutions to accelerate time-to-market. As a full-service CDMO, Simtra supports clients from clinical development through commercial launch with expertise in aseptic operations, quality systems, and global regulatory compliance. The company is currently implementing a $250+ million expansion at its Bloomington facility to enhance syringe fill lines and lyophilization capabilities.