At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
Descripción del Trabajo
This position has the responsibility and authority to lead a local team to ensure planning, preparation, execution and follow up of internal audits, customer audits, certification body audits, FDA or other country authority inspections and when required prepare submissions and responses to FDA, other country authorities, certification bodies, and customers. This position will serve as the primary contact for other departments at the assigned site and will work closely with direct reports to provide guidance and development opportunities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Jabil, procedures and guidelines, this position is responsible for leading:
- External inspection readiness and associated activities. Lead site audit readiness activities to ensure inspection readiness at all times.
- Support external audits as Compliance SME: e.g., Notified Body, Ministry of Health country inspections, FDA, Customer Audits, Jabil Global Audits for site.
- Participate in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.).
- Ensure assessments of the risk and applicability of audit observations from other Jabil sites to determine impact to the site.
- Support mock inspections as part of External Inspection Readiness activities.
- Ensure timely provision of information to support the inspection process.
- Internal Audit Program Execution against established internal audit procedures.
- Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.
- Drive Compliance improvements, which result from audits, Gemba walks and other system indicators.
- Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
- Connect and collaborate with other site/ regions compliance teams.
- Create reports and communicate performance against metrics to key stakeholders.
- Highlight/communicate adverse trends in metrics and take risk-based action to remediate.
- Escalate items in accordance with established procedures.
- Support implementation of new external standards/regulations for the site.
- Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations, and industry meetings.
- Provide input into Site Management Reviews (e.g., internal audits) to allow meaningful review.
- Establish strong connection and collaboration with business partners at the site (e.g., Quality, Operations, Training, and Manufacturing).
- Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
- Support and promote the safety and environmental objectives of the facility. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
- Communicate business related issues or opportunities to next management level.
- Perform other duties assigned as needed.
- Perform all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements.
- Extensive knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485, MDD/MDR, and ANVISA)
- Some experience with compliance assessments, gap assessments and risk management assessments.
- Experience with program change management practices, lean or six sigma, program and system integration efforts.
- Strong computer skills: Word, Excel, PowerPoint
INTERPERSONAL SKILLS / CHARACTERISTICS:
- Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally.
- High Attention to Detail
- Ability to make complex issues simple
- Excellent Communication Skills (written & oral)
- Team Player
- Excellent time management
- Focus on achievement and delivery of results
- Active Listener
- Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment and influence change without alienating others.
- Must have a high tolerance for ambiguity.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor’s degree required (Quality, Regulatory, Engineering, Business, Life Sciences, or another technical field)
- Master’s degree is desired (Quality, Regulatory)
- At least 6 years' working experience in a regulated industry, and managing high performing teams
- At least 3 years’ experience in a quality and/or compliance function
- Experience in performing audits is recommended
- Experience in interaction with Health Authorities and Notified Bodies is recommended
- Lead Auditor qualification is recommended
- Regulatory Affairs Professional Society (RAPS) Certification is desired
- Or a combination of education, experience and/or training.
- Available to occasional, infrequent travel
- Minimum of business fluency in English
- Fluency in Spanish highly desired
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.