Supplier Auditor

Work with the global manufacturing/services network acting as a liaison to ensure all Pharmaceutical Services Group (PSG) suppliers (material and service) continue to deliver quality products and services to the company. 

Participate in the PSG Global Supplier Quality (GSQ) team, performing supplier audits,maintaining supplier auditreports andmanaging / negotiating CAPA responses.

Lead communication related to supplier audits with suppliers and impacted sites.

Maintain audit plan status, handling Global Supplier Quality Agreements,and communicating with suppliers where appropriate to achieve these tasks.

Plan, perform and oversee the auditing process which includes timely completion of audits and agreements in the appropriate electronic-Quality System (TrackWise). 

Lead or participate in PPI projects and initiatives to develop and implement improvements in GSQ. 

Responsible for reviewing cGMP documentation and may be responsible for authoring cGMP documentation, developing and delivering training for GSQ related topics. 

SupportPSG manufacturing network with supplier quality, auditing and change notification activities and liaison with respective functions such as, Legal, Procurement, Supplier Change Notification and Supplier Performance Monitoring. 

Providesupplier quality management guidance / support to the PSG manufacturing networkduring Client / Authority inspection.

Education:

A minimum of a Bachelor’s Degree is required in Engineering, Science, or Business

Experience:

A minimum of 5-10 years of relevant experience in a GMP environment, in any of the following industries: Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements, is required.  

Knowledge and understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

Knowledge and use of Quality ComplianceSystems (Trackwise, etc).

Experience in a matrix organization.

Experience with supplier auditing and supplier quality management 

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Knowledge of regulatory requirements and cGMPs, such as FDA, EU, ISO

Strong communication skills (verbal and written), including technical writing.

Appreciates and respects diversity, cultures, and norms.

Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint).  

Proven self-starter with strong time management skills and the ability to work within a team as well as independently.

Must be able to multi-task and respond to shifting priorities.

Ability to learn new software and tools quickly.

Ability to perform all qualifications and job responsibilities within a multi-site, global, remote team.  

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.