Quality Manager, IMP Quality Systems & Compliance

Cambridge, MA, USA
Nov 09, 2017
Dec 04, 2017
Contract Type
Full Time
Job Type
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Manager, IMP Quality Systems & Compliance in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Manager working on the IMP Quality Systems & Compliance team, you will be empowered to be a Subject Matter Expert for IMP Quality Systems, and a typical day will include:




* The Quality Manager, IMP Quality Systems & Compliance manages quality systems and cGMP compliance efforts for the regional IMP Quality organization.

* This position is responsible for providing strategic support in monitoring the compliance of key Takeda vendors, tracking quality performance metrics, and partnering with internal stakeholders in providing feedback and direction to improve vendor performance and ensure ongoing compliance.

* The Quality Manager, IMP Quality Systems & Compliance is expected to independently manage projects and make sound decisions related to supplier quality and compliance issues.


* Collect, analyze, and report GMP performance metrics associated with the pharmaceutical development supply chain. Make recommendations to management based on analysis of performance metrics.

* Support development of IMP Supply Chain compliance and control strategy and execute effectively. Ensure that IMP supply chains maps are documented and kept current.

* Perform risk assessments of the IMP supply chain and make recommendations to management based on the results.

* Independently and proactively provide communication to management on new and outstanding supplier quality and internal compliance issues.

* Have strong knowledge and understanding of the global IMP supply chain. Identify and analyze risks and quality issues, and develop mitigation strategies.

* Collaborate effectively with Global Quality Auditing, IMP Quality, and other applicable groups to ensure creation, accuracy, and maintenance of an annual supply chain audit schedule. Execute an effective strategy to ensure audits are conducted as required.

* Ensure appropriate Quality Agreements are in place and maintained with all 3rd parties across the IMP supply chains. Ensure vendor agreements reflect supply chain compliance requirements.

* Manage internal quality metrics pertaining to IMP Quality and Pharmaceutical Sciences; assess the results in collaboration with internal stakeholders.

* Identify and initiate process improvement opportunities pertaining to the GMP quality management system.

* Additional duties as assigned.


* Bachelor's Degree in Chemistry, Biology, Engineering or related field.

* Minimum of 6 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 4 years in GMP QA or Compliance.

* Experience working with a global outsourced-based supply chain.

* Knowledge and understanding of pharmaceutical GMP regulations ability to apply & interpret in support of Takeda activities.

* Demonstrated teamwork, initiative, and problem solving skills.

* Strong oral/written communication skills.

* Strong relationship management and interpersonal skills. Essential skills include collaboration, maintenance of focus, consensus-building, negotiation and conflict resolution, de-escalation, relevant concept identification and focus on facts, and listening.

* High attention to detail.


* Routine demands of an office based environment.


* Requires approximately 5% travel, both domestic and international.


* 401(k) with company match and Annual Retirement Contribution Plan

* Tuition reimbursement

* Company match of charitable contributions

* Health & Wellness programs including onsite flu shots and health screenings

* Generous time off for vacation and the option to purchase additional vacation days

* Community Outreach Programs

*Empowering Our People to Shine*

Learn more at*takedajobs.com*.

*Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx*

*No Phone Calls or Recruiters Please.*


**Job:** **Research and Development*

**Title:** *Quality Manager, IMP Quality Systems & Compliance*

**Location:** *MA-Cambridge*

**Requisition ID:** *1703028*