Unity Lab Services is looking for an Audit Program Manager to take a lead role in developing an “end to end” audit program for our multi-site organization within North America. The role will include building a team of compliance experts to perform annual internal audits as well as managing all external audits (ISO, Corporate, Customer and Suppliers). The candidate must have exceptional drive, strong leadership and effective communication skills to harmonize the business (and program) to meet the compliance standards of ISO 9001, 13485 and the applicable elements of FDA’s 820 Quality System Regulation. The role also includes interaction with the supplier qualification process by evaluating surveys and performing supplier audits that are categorized as high risk.
- Plan, develop and sustain a premier internal and external audit program for a multi-site organization with all processes in compliance with ISO, regulatory agencies, corporate and customer requirements.
- Collaborate with relevant Quality team members to evaluate, deploy and standardize on an audit software solution to assure a high level of program effectiveness, repeatability and compliance on a global scale. System to support applicable forms, checklists, report templates, calendar and communication tools.
- Develop, manage and sustain the auditor training program:
- Define, develop and deploy adequate audit training criteria and levels based on the requirements of the highest applicable quality standard.
- Ensure all trainings are assigned and maintained via company training matrix program.
- Ensure auditor qualifications and certifications are adequate, current and maintained per program requirements.
- Manage the internal audit program:
- Plan, organize and deploy the annual internal audit strategy, scope, plan and schedule based on previous audit reports or identified risk areas.
- Collaborate with organizational leaders to gain support of the audit program and provide adequate volunteer levels by site.
- Build a cross functional internal audit team to complete annual audits by site and including all field based operations (audit prep, audit report, manage non-conformities).
- Review and approve audit reports prior to report out and system processing.
- Manage external audits (ISO, Corporate, Customer and Suppliers):
- Serve as the primary contact for all external audits by interacting and communicating with pending auditors to verify scope, audit plan, schedule and locations.
- Prepare site(s) and employees for external audits
- Ensure proper functional leaders or subject matter experts (SME’s) are identified and notified in advance based on audit schedule.
- Organize, train and prepare SME’s, scribes and personnel for potential Inspections.
- Lead Auditor & member of the supplier evaluation and qualification process:
- Participate in new supplier evaluations to place potential suppliers in appropriate “risk categories”.
- Organize, schedule and complete audits of suppliers that are classified as “high risk” along with completing related audit reports.
- Engage and act on post audit activities:
- Communicate, collaborate and educate organizational leadership to assure full understanding and commitment of the standards, related findings and provide examples “in real terms” of how to meet them.
- Communicate and collaborate with CAPA Specialist to assure findings are processed adequately and timely per established procedures.
- Participate in “assignment review” meetings as needed.
- Generate audit metrics and reports needed for status communications and Quality reviews
- Support and or provide input to key quality initiatives and or projects as required
- Occasional interaction with global quality team members and or business
- Responsible for other duties as assigned by manager as necessary
- Bachelor’s degree required
- 3-5 years experience / knowledge as a Lead Auditor, including performing supplier audits and qualifications (Lead Auditor certification preferred )
- 3-5 years applied experience of implementing ISO9001, 13485 and FDA’s QSR 820 requirements
- An experienced team builder with ability to work collaboratively with various departments to identify and implement solutions to address quality/compliance issues
- Self Motivated, Self Drive and Discipline to assure tasks are timely.
- Proven Time and Project Management skills.
- Experience in development and authoring of quality procedures, work instructions and forms.
- Use of Microsoft Word, Excel, PowerPoint, Outlook and Visio.
- PPI application and experienced
- Excellent written, communication and strong critical thinking skills
- Willing to travel up to 30% including Canada
Location: focus areas: Madison, WI, West Palm Beach, FLA, Pittsburgh, PA, and Marietta, Ohio. Candidate can work remote in eastern USA.
No direct reports.
This position is not approved for relocation assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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