Job Information
Jabil Inc. Site Compliance Manager - J2390803 in West Chester, Pennsylvania
Site Compliance Manager - J2390803
DESCRIPTION/RESPONSIBILITIES: Jabil is seeking a Site Compliance Manager to work in the West Chester, PA location.
How will you make an impact? As the Site Compliance Manager, you will lead internal audits, customer audits, ISO Registration audits, and FDA Inspections, and when required prepare submissions and responses to FDA and ISO Registrars. This position will serve as the primary contact for site departments, business units, and corporate functions and will work closely with direct reports to provide guidance and development opportunities.
What will you do? * Lead internal audits and supplier audits. * Lead the readiness program for ISO Registration audits, FDA Inspections, and customer audits. * Prepare submissions and responses to FDA and ISO Registrars. * Act as the primary compliance contact for site departments, business units, and corporate functions. * Act as a subject matter expert for the Quality Systems and Compliance programs. * Ensure the site's quality system development, effective maintenance, and continued compliance with business unit requirements, medical device regulations, and standards (i.e., U.S. -- FDA, ISO 13485, Anvisa). * Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes. * 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
How will you get here? Education: * Bachelor's degree required in Quality, Regulatory, Engineering, Business, Life Sciences, or a similar related industry. * Master's degree is preferred in a Quality, Regulatory discipline OR a combination of education, experience and/or training. * At least 6 years of industry experience within Quality and/or Regulatory and managing high-performing teams.
Experience: * At least 6 years of industry experience within Quality and/or Regulatory and managing high-performing teams.
Knowledge, Skills, Abilities: * Experience with compliance assessments, gap assessments, and risk assessments. * Experience with program change management practices, lean or Six Sigma, and program and system integration efforts. * Strong communication skills, both verbal and written. * Knowledge of the U.S. and international medical device quality system regulations, standards, and best practices (21 CFR 820, ISO 13485).
Benefits you will receive while working with Jabil: Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes: * Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options * 401K match * Employee Stock Purchase Plan * Paid Time Off * Tuition Reimbursement * Life, AD&D, and Disability Insurance * Commuter Benefits * Employee Assistance Program * Pet Insurance * Adoption Assistance * Annual Merit Increases * Community Volunteer Opportunities
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 the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatev r website it was posted in.
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 identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.