Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.
We have several locations across the US and are looking for new Associates to join our team!
The purpose of the Senior Manager, Supplier Quality is to manage a team who ensures PDI s internal and external audit programs are in compliance with corporate policies, industry standards, and applicable regulations. Activities also include conducting a variety of audit activities focusing on: suppliers (raw materials, components and non-woven, etc.), contract manufacturers, laboratories and service providers, and internal PDI departments.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Schedule, plan, execute, report, follow-up and close internal and supplier audits (GMP, GLP, GCP, ISO, etc.) Monitor and track audit corrective action plans Develop an enhanced Quality Audit System to reduce risk and increase compliance Conduct risk assessment on the suppliers according to the corporate policies Participate in investigations and conduct For cause audit Provide audit summaries to annual management review Lead and develop Audit Manager team Maintain the Approved Supplier List Develop and maintain related SOPs and policies Maintain and file audit reports and corresponding documents Utilize electronic systems for documenting, tracking, and reporting audit activities. Provide various project teams the evaluations of the compliance status of the suppliers. Work with corresponding departments to consolidate supplier audits, and optimize timelines for auditing activities. Recommend approved suppliers for various commodities Evaluate the audit findings and conclude the audit results as Not Approved , Conditional Approved and Approved . Assist procurement department and site quality departments for vendor rating, and supplier scorecard activities. Develop and publish internal department and supplier audit metrics.
1. On time completion. 2. Robustness of program. 3. Training and certification compliance. 4. Values - centered execution. RequirementsQUALIFICATIONS
Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent). Advanced degree preferred.
Proficiency in Microsoft Office, Internet Browsers, and Adobe PDF applications.
Minimum 5 years of experience in FDA regulated industries (pharmaceuticals and medical device) with 3 years in a cGMP audit role. Prefer a person which has both pharmaceutical and device experience. Working knowledge of 21 CFR 210, 211, 820, ICH, ISO 9001, 13485, 22716
Expert knowledge of the GMP Quality System and regulatory requirements in accordance with FDA regulations and ISO Standards. Excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments. Must be able to apply sound risk management. Must have expertise in interdisciplinary areas of pharmaceutical sciences, operations, validation, analytical chemistry, microbiology, cGMPs and regulatory issues. Strong written and verbal communication skills with all organizational levels and external partners. Ability to troubleshoot complex problems.
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. Please view Equal Employment Opportunity Posters provided by OFCCP here. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Please refer to the Company s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.