Quality Assurance Manager - Chesterfield, United States - Synectics

Description

5 days ago

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You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors.

You will be the Vendor Point of Contact responsible for the quality management of approximately 25 contract manufacturers, packager, contract test laboratories, and supply partners globally.

Focus on developing relationships, independently negotiating, developing and communicating quality requirements with contract vendors.

Your expertise provides quality system leadership to operational teams, drive process improvement, advancing new concepts and methodologies that will make us ready to achieve new milestones and help patients worldwide.

Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people.
Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and expectations.

Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate.

Provides project support with current Good Manufacturing Practices to clinical supply packaging operations.
Provides guidance on procedures and training necessary to be in complete compliance with current GMPs.

Job Description

You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors.

You will be the Vendor Point of Contact responsible for the quality management of approximately 25 contract manufacturers, packager, contract test laboratories, and supply partners globally.

Focus on developing relationships, independently negotiating, developing and communicating quality requirements with contract vendors.

Your expertise provides quality system leadership to operational teams, drive process improvement, advancing new concepts and methodologies that will make us ready to achieve new milestones and help patients worldwide.

Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people.
Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and expectations.

Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate.

Provides project support with current Good Manufacturing Practices to clinical supply packaging operations.
Provides guidance on procedures and training necessary to be in complete compliance with current GMPs.

Qualifications

BS Preferred (open to 5 + years' experience in lieu of degree)
Vendor Quality Management experience in Pharma industry
cGMP
Project management background
MS Office skills
Relationship building skills
Negotiation skills
Auditing skills

SAP
Benefits


Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Premiums are subsidized by Synectics.


Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance:
Synectics offers eligible employees vision insurance through VSP.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k)

Plan:
The Synectics Inc. Investment Savings Retirement Plan.

Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins.

Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.


Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.

In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.

Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus.

It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Seniority level

Seniority level

Mid-Senior level
Employment type

Employment type

Contract
Job function

Job function

Quality Assurance
Industries

Biotechnology Research and Pharmaceutical Manufacturing
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