Sr. Specialist, Supplier Quality Management

Cardinal Health

11d•$68,500 - $88,020

About The Position

The Sr. Specialist, supplier quality management executes quality programs, policies, and procedures in a particular area of specialty (such as change controls, SCARs, Risk Assessments, and Quality Agreements) to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due to a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area.

Requirements

2-4 years of experience preferred
BA, BS or equivalent experience in related field preferred
Reports to Supplier Quality Management (QRA).
Demonstrates knowledge of supplier quality /quality systems and approaches.
Demonstrates an understanding of the relevant FDA regulations, standards and operating procedures for supplier qualifications.
Demonstrates knowledge of Supplier Quality as it relates to pharmaceutical products.
Manage the supplier risk assessments and quality agreements for all Private Label suppliers and services.
Demonstrate knowledge of Quality System processes for suppliers
Demonstrates an understanding of the requirements and can perform gap assessments to those requirements.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, auditing, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes action to resolve
Applies judgment within defined parameters
Receives general guidance and may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Manages professional employees and/or supervisors; may manage business support, technical or production staff. Applies expertise to improve effectiveness and provide guidance to employees in own area.
Has accountability for managing financial resources. Manages budget for own area and allocates resources, accordingly, applying knowledge of profit drivers within own area/job family.
Role models Cardinal Health's high ethical standards and code of conduct.
Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs.
Builds confidence and respect of others through a positive and energizing style.
Interprets internal/external business issues and adapts work priorities in own area.
Works with customers to anticipate and interpret customer needs and business challenges by identifying quality and service-oriented customer solutions and shares key learnings with others.
Effectively solicits and explains difficult concepts and persuades others to adopt a point of view, states own point of view.
Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.

Responsibilities

Negotiate suppliers Quality Agreements commitments prior to QRA Management approvals (by ensuring preparation of the adequate documentation) of the agreement.
As a member of the Quality Supplier Management Program, will evaluate suppliers in compliance with Good Manufacturing Practices and regulatory requirements.
Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.
Reviews, comments and challenges in an appropriate way, the Quality Reviews for the supplier’s quality agreements status.
Understands technical supplier issues and evaluate their potential impact on product quality and compliance.
Escalates complex issues to management in a timely manner.
Prioritizes and ensures work is delivered in an efficient way.
Represents QA in meeting related to his/her area of responsibility (suppliers meeting, , change control, audits planning and review, budget, etc.).
Addressing CAPA’s from external audits.
Conducting a management review (for suppliers) of the quality system.
Following-up on and closing pending preventive and corrective action requests.
Performs other job duties as assigned.