Our client is a FORTUNE 500 company and global leader in consumer products and medical devices who offers a wealth of career growth opportunities that allows you to reach your full potential. Our client is currently looking for a Technical Audit Leader to lead the North America Supplier Compliance Audit Program.
Will work under the direction of the Director of Global Compliance Audits and will manage several aspects of the Compliance Audit function. The role will manage the overall North America Supplier Compliance Audit program, including but not limited to:
- Manage and continuously improve the Supplier Compliance audit process in NA.
- Facilitate and provide guidance and direction related to compliance activities including alignment with new regulations related to their field of expertise
- Coordinate cross-functional teams in the development and execution of compliance programs, evaluate facility audit programs and special technical gap assessments.
- Develop and maintain metrics associated with the Compliance program;
- Act as global Internal Manufacturer or Supplier QA Compliance SME;
- Assure the integrity and reliability of information systems and the Company's Health Compliance Audit Schedule and risk assessment process,
- Evaluate, approve and monitor corrective actions derived from the compliance audits; coordinate as needs joint audits and special compliance gap assessments with other groups,
- Facilitate FDA readiness training for internal manufacturers;
- Support FDA and external audit activities across multiple locations;
- Identify issues and drive compliance improvements to ensure efficient regulatory compliance and reduced compliance risk
- Assess and qualify supplier and evaluate risk associate with transfer activities between internal manufacturers, new acquisitions and suppliers.
- Act as an SME coach to drive compliance activities across different locations.
- Manage the compliance audit program for internal operations or supplier qualifications to ensure process and product conformance to the Company’s corporate and industry regulatory requirements.
- Provide expertise pertaining to the development of compliance and quality systems, enhancement of manufacturing site quality systems, internal and external compliance auditing, enhancement of supplier quality systems, quality and productivity improvement support, material and the due diligence for major acquisitions.
- The incumbent is responsible for maintaining and/or enhancing existing Quality functional systems in a manner that effectively supports growth of the Health Care sector.
- Will provide support during FDA inspections of regulated facilities.
- Will support suppliers during FDA inspections that could impact or disrupt the company’s business.
- Expected to understand the Company’s business needs and participate in compliance activities between Global Quality and the business teams, suppliers and contract manufacturers.
- Understand complex manufacturing processes to enable the development and implementation of tools and systems to support continuous process and product improvement.
- Understand complex product failure situations including but not limited to design activities, reliability, risk assessment, inspection and validation requirements.
- Support greater than $1 Billion in medical device, and prescription drug product manufacture and sales, and evaluate potential acquisitions of approximately up to $2 to $3 Billion with potential material impact on the Corporation. Indirect budget accountability of approximately $500,000 USD.
- B.S. in Engineering (Electronic, Electrical or Mechanical), Science (Microbiology or similar) or related field
- Certification as CBA, CQA or ISO 13485 Lead Auditor (strongly recommend or to be obtained during the first 3-6 months in the position)
- Must have at least 5-10 years of experience in QARA medical devices, pharmaceutical, biologics, or other highly regulated industry in any of the following technical area: (QA engineering, manufacturing of electronic medical devices, software development).
- Must have 3-5 years of experience conducting gap assessment, risk analysis of complex failure investigations (i.e. validation deviations, customer complain investigations; field action investigations; audit observations, etc.).
- Experience as an Internal Auditor, Lead Auditor, Project Management coordinator or coordinating complex gap assessments of manufacturing process or product related issues (strongly recommended but not mandatory if the individual is a strong technical expert).
- General Knowledge of Quality System requirements like: 21CFR820, 21CFR210/211, ISO 13485, ISO 9001, JPAL MO 169, CMDCAS SOR 98-282, ANVISA RDC 16, TGA Reg 2002, etc.
- General knowledge of any of the following technical standards: ISO 14971, IEC 60601, 21CFR Part 11
- Strong technical skills expertise (product validation, process, validation, software validation, reliability, risk assessment, statistical techniques) (Highly desired)
- Proven record of successfully working in a global environment
- Due to the high interaction with Global locations, a fully bilingual (English plus one of the following languages: Spanish, French, Mandarin, Japanese) is highly desired
- Excellent written and verbal communication skills
- Excellent instruction/teaching skills
- Availability to have a high travel schedule (approximately 30-50% of the time)
- Ability to work independently and work closely in a team environment.
- Strong presentation and interpersonal communication skills.
- Proven leadership and ability to work closely with audit coordinators both internal and external with suppliers.
- Problem solving skills with use of statistical analysis.