Quality Client Partner - Pharma Compliance

Simtra US LLC; Bloomington (IN); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 1:

Paid Holidays

Paid Time Off

Parental Leave and more

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Community and Volunteer Service Plan

Employee Ownership Plan

Disability Insurance

Voluntary Insurance Benefits

Onsite Campus Amenities

Job summary

Simtra US LLC is seeking a Quality Client Representative to join the core client team. You will interact directly with clients and lead all quality aspects of projects, delivering exemplary service by focusing on quality and compliance. This role reports to the Quality Manager.

You will act as the primary quality contact, manage updates, make timely quality decisions, escalate issues, and partner with multiple departments to ensure consistent quality information and project success.

Qualifications

• Bachelor's degree in a science-related field with 5 years pharmaceutical experience, or a Master's degree with 3 years 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, Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, 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.

Education

Bachelor's degree in science-related field

Master's degree in science-related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Enterprise software (JDE, Trackwise, Pilgrim, etc.)

Job description

Simtra US LLC is seeking a Quality Client Representative to join the core client team. You will interact directly with clients and lead all quality aspects of projects, delivering exemplary service by focusing on quality and compliance. This role reports to the Quality Manager.

You will act as the primary quality contact, manage updates, make timely quality decisions, escalate issues, and partner with multiple departments to ensure consistent quality information and project success.