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We are searching for the best talent for Manager Regulatory Compliance to be in Sao Jose dos Campos, Brazil.
You will be responsible for : * Manager Regulatory Compliance is expected to provide key oversight and support for Regulatory Compliance and Outreach for the sites.
Establishes internal strategies, policies, procedures, processes, and programs to prevent violations of law, rule, or regulation and design and deliver a risk management framework that maintains appropriate levels of risk and protects the company * Implement and execute internal audits program at the site (schedule, agenda, prepare and conduct audit, report writing, review of internal audits investigation responses).
* Responsible for training and qualifying auditors.
* Facilitate, support and host as needed the external GMP audits and inspections (Health Authority, Customer), including the coordination of inspection back room.
* Lead the Inspection Readiness process for announced and unannounced Health Authority and Notified body audits and lead compliance walk-throughs, audit preparation, coaching the SMEs.
* Support the development and review of external Health Authority and notified body observation responses (appropriate response, investigation, corrective actions, timing, execution) * Provide compliance subject matter expertise to the manufacturing site, including identifying changes in regulations that impact procedures and current practices.
* Implement compliance initiatives and projects at the site, in alignment Johnson & Johnson Regulatory Compliance (JJRC) and with MedTech and Ethicon policies and procedures.
* Partners with stakeholders (e.g., quality operations, source quality, franchise quality, quality systems, manufacturing, and other cross-functional business functions.)
for the identification of potential quality or compliance issues and development of corrective action plans.
Monitor the effective and timely implementation of these corrective action plans.
* Ensure that Quality and Compliance metrics are captured consistently and accurately, and communicate performance against metrics to key stakeholders.
* Responsible for maintaining high quality standards for the product manufacturing process at the site in compliance with all applicable regulatory requirements.
* Leads compliance professionals at the site and is accountable for meaningful career development conversations and regular coaching and feedback.
* A minimum of a Bachelor's Degree or equivalent experience in Engineering or Pharmacy or Science or related field.
* At least 8 years related experience in a GMP-regulated industry * 2-3 years of experience in a supervisory/management role is preferred.
* Experience handling and/or supporting inspections.
* Strong analytical skills and ability to clearly articulate issues.
* Excellent interpersonal skills, able to quickly build credibility with the site and within the Quality and Compliance community.
* Fluent English level * Expertise on Health Authority and Medical Device Quality System regulations, with the ability to relate these to business/quality issues.
* Experience performing internal audits is strongly preferred (lead auditor certification).
* A creative, flexible approach to new challenges!
* Domestic / International travel is possible (5%-10%) * This is a Flex position that requires 3 days on site, and 2 days remote, with exception of audit and inspection period, where on site presence is needed.