QA Compliance Manager

Job ID
2020-2382
Category
Quality Assurance & Regulatory Affairs
Location : City
Madison

Job Description

JOB OBJECTIVE: Leader of the internal audit program within the Promega quality system to meet internal and external requirements. Actively support the facilitation of customer and other external party audits.


ESSENTIAL DUTIES:


Internal Audit


1. Develop and execute the internal audit program including planning, organizing, and conducting (or ensuring the completion) of internal audits in accordance with an approved internal audit schedule.


2. Perform a comprehensive, risk-based, balanced review of the quality system through internal audits. Communicate the outcomes of internal audits to auditees and other stakeholders.


3. Generate and maintain internal audit records necessary to demonstrate adherence to internal and external requirements. This includes: audit plan, audit certificate, audit report, audit responses, and objective evidence.


4. Conduct re-audits or verification of effectiveness activities to support the quality system.


5. Develop and maintain tracking and trending metrics to monitor internal audit activities and identify trends as it relates to the adequacy and effectiveness of the quality management system. Initiate action based on the results of tracking and trending. Prepare and present information to stakeholders.


6. Train and coach others on how to conduct effective audits.


7. Identify and recommend improvements to the internal audit program.


External Audit


1. Help prepare for and facilitate external party audits including customer audits and regulatory body audits.


2. Present and discuss the internal audit program to customers and regulatory bodies during external audits.


3. Work with management and others on audit activities or corrective actions needed for the business.

4. Conduct verification of effectiveness assessments of external audit findings to support the quality system.


5. Understand and comply with ethical, legal and regulatory requirements applicable to our business.


6. Develop and maintain tracking and trending metrics to monitor external audit activities. Prepare and present information to stakeholders.


7. Positively represent Promega in discussion and interactions with customers and other external parties.


8. Develop ideas on how to improve external audit processes.


OCCASIONAL DUTIES:


1. Lead or participate in cross departmental or corporate projects or initiatives as assigned.


MANDATORY QUALIFICATIONS:


1. Bachelor’s degree in the life sciences with ten (10) years of relevant industry experience.


2. Excellent working knowledge of domestic and international regulations applicable to the design, development, manufacturing and marketing of medical device diagnostic reagents.


3. 5 to 10 years’ experience in performing compliance audits in an ISO, FDA or internationally regulated (EU) environment.


4. Excellent interpersonal, leadership and coaching skills.


5. Demonstrated ability to prioritize and coordinate multiple tasks under deadlines.


6. Foster and work in a positive team environment.


7. Demonstrated knowledge and experience in various computer skills, including Windows, Word, Excel, Outlook, Visio, as well as familiarity working in a Windows-based environment.


8. Effective written and oral communication skills, including formal presentations, coaching, and problem resolution.


PREFERRED QUALIFICATIONS:


1. Professional certification in good standing in the life science industry, e.g. such as ASQ Certified Quality Auditor, specialization in Biomedical Industry, RAB or audit certification to the applicable version of ISO 13485.


2. Independent, self-starter with proven results in problem identification, planning, communication and project management.


3. Ability to articulate technical and interpersonal issues and resolve conflict in a constructive manner to ensure project success.


4. Ability to work and communicate well with a diverse scientific, business, and organizational group to achieve improvement and operational results.


5. Experience in achieving results in a rapidly changing, cross functional environment.


PHYSICAL REQUIREMENTS:


1. Ability to use computer equipment.

 


Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

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