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QA Manufacturing Director

3 months ago

Morristown, United States Actalent Full time

Job Title: QA Manufacturing Director

Job Description

In this position, the Director develops strategic direction and provides the governance/oversight of the this segment of products operations that comprise the company's portfolio. The Director leads the team that directly interacts with company's external business partners/CMOs and has responsibility for oversight of multiple complex sterile products and medical devices throughout the entire lifecycle of the product (i.e. from development through final decommissioning and disposal) and is responsible for supporting the adherence to company's Quality Management System. This individual is a critical link between companys external partners and the internal team (e.g. Operations, Supply Chain, Business Development, R&D, Product Launch, Regulatory Affairs, Global / Corporate Quality, etc.). The individual will also be responsible for supporting companys US Regional Quality Group with Quality Management Systems improvements / enhancements. The position will require a strong first- hand knowledge of the regulations and international standards governing Medical Device and Combination Products distributed in multiple commercial markets within the US, EU and ROW i.e., QSRs, ISO 13485 and MDRs. Being able to effectively communicate and transmit information to/from the partners is essential to ensure compliance and optimal performance. Be able to effectively multi-task in a fast-paced environment while demonstrating strong collaborative skills with comapnys internal and external customers

Hard Skills

+ Needs to have compliance quality experience

+ Experience with complex and critical deviations/CAPAs/Investigations/change controls/batch record review

Job Type

This is a Contract-to-Hire position with a duration of 6 Month(s).

Work Site

This is a hybrid schedule, position in Morristown, New Jersey.

Work Environment

Working in GMP environment

The position has the GMP decision making authority regarding the disposition of batches. Through the Quality team, and as required, approves all standards, specifications, master batch records, procedures, validation protocols and reports, change controls, batch records, deviations and release of acceptable products.

Approximately 25-30% business travel required to external Contract Manufacturing Organization (CMO) / Business Partner sites, to attend professional development training seminars, or otherwise as directed by the Sr. Director of Third-Party QA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.