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Quality Assurance Vendor Quality Manager

Newark Metro Area, NJ

Posted: 04/13/2018 Job Type: Scientific Job Number: JN -042018-21328
Description:
This position provides quality oversight for contract or internal manufacturing organizations used to manufacture drug substance (API) and/or drug products in accordance with policies, standards, procedures and international cGMP s. The incumbent will oversee multiple products at various Contract Service Providers (CSPs).

Reports to: Director of QA Operations
Prerequisites (As Applicable) 7-10 years pharma QA experience

Travel details (there's a 5% chance for travel):

Both domestic (USA) or international (mostly Europe)
Domestic travel can either be via driving or flying (depending on geographical location) and likely not more than 2 days at a time
International trips would likely not be more than 3 days at a time. Typically, one day of doing work at a CMO and 2 days of travel
If the candidate is not able to travel, it is not a show stopper and manager can work around it. Please put a note in the Supplier Comment Section as to whether or not the candidate has the general ability to travel.


1. PURPOSE AND SCOPE OF POSITION:

This position provides quality oversight for contract or internal manufacturing organizations used to manufacture drug substance (API) and/or drug products in accordance with policies, standards, procedures and international cGMP s. The incumbent will oversee multiple products at various Contract Service Providers (CSPs).


Partner with Technical Operations to identify and qualify Contract Service Providers (CSP).
Serves as the Quality Ops single point of contact and is responsible and accountable for the quality and compliance performance of the assigned CSP(s).
Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner.
Responsible for the content of the Quality Agreement and ensures compliance.
Partners with Technical Operations to assess overall product quality performance, including identifying any product-specific quality and compliance risks and develops a mitigation plans based on a risk based approach.
Final Quality Operations approver of all Vendor GMP documents that require Quality approval such as Investigations, Deviations, Change Controls, Validation documents, Specification, etc. (under the supervision of Dev QA management)
Develops, collects and/or monitors Quality metrics, assesses the results in collaboration with Technical Operations, develops corrective actions with the vendor Quality unit and reports results to management.



Skills:
Must have expert cGMP and Quality knowledge.
Must know how all stages of product development interrelate and how decisions or actions taken affect functional partners within and outside the Dev QA organization.
Must be able to critically interpret problems and effectively communicate in a productive manner to management, cross functional SMEs, and the broader organization with clarity and a high level of brevity and accuracy.
Must be able to recognize and group technical/scientific attributes in potential situations or issues and drive compliance based decisions across the function.
Must be able to critically interpret results and generate technical conclusions consistent with Quality risk principles.
Must be skilled in planning and organizing, conflict management, coaching others, decision-making, building relationships, and innovation management.
Thorough knowledge of and competence in core quality processes, including material disposition, change control, product complaints, deviations, root cause analysis, and CAPA management
Excellent verbal and written communication skills
Ability to author, review and approve technical documents.
Ability to author, review and approve investigations, quality technical agreements, and risk assessments. Ability to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc.
Ability to assess when escalation to management is required
Ability to share information about current interpretations and application of regulatory expectations between the decision-maker and other stakeholders.
Understanding of assigned product and related processes and technologies
Understanding of KPIs and operational metrics
Working knowledge of international GMP requirements/expectations and industry standards.
Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
Ability to make independent and objective decisions and to work with minimal supervision
Negotiation and influencing skills with integrity are important.
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