Senior Manager Commercial Quality

2 months ago

Dublin, Dublin City, Ireland J&J Family of Companies Full time

Senior Manager Commercial Quality - Vision W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

J&J MedTech is recruiting for a Senior Manager Commercial Quality - Vision reporting to the Director Commercial Quality.

Job Position Summary

Accountable for CQ WW metrics oversight, collection, review, reporting and roll-up. Responsible for producing insightful and meaningful trending which translates, where needed, to tangible actions. Runs the monthly QMS reviews with the Leadership Team to assess the adequacy of the QMS.

CQ input into Franchise Management Review, preparation of CQ slides. Responsible for Regional Site Management Review alignment on global QMS topics. Responsible for developing and communicating departmental materials for Management review, when applicable.

Accountable for the overall oversight of ICQAs management and update worldwide. Ensure Vision CQ has appropriate visibility of all those ICQAs part of its QMS as well as its periodic review. Coordinate reviews on a timely manner with SMEs, approvers and document owners.

This role acts as the Vision Commercial Quality (VCQ) lead for Digital transformation and Data Analytics.

Provides support on the revision and determination of applicability of the J&J Standards.

Applicable documents owner.

Support the preparation, hosting and logistical planning for corporate (ERC) audits, internal audits. Serves as company representative during such audits, facilitating communications, facility touring, information requests, follow-up activities and corrective action/remediation plans as needed.

Management and timely completion of audit actions resulting from the regulatory compliance audits. Support the regions and Marketing

Companies on internal, corporate and other regulatory audits and inspections.

Leads regional Market Company and global internal audits in accordance with defined procedures and schedules.

Ensure accurate reporting, response review and approvals, communication of issues, and use of tracking and trending tools.

Leads and/or supports Quality and Compliance projects and project teams, as needed, with identification of quality system requirements to ensure compliance.

Promotes a culture of Regulatory Compliance and Risk Management throughout the organization.

Supports departmental and Franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.

Drives continuous improvement projects that are consistent with established and evolving regulatory and company requirements.

Deploying vital training as a refresher to the overall CQ organization as well as pro-active identification of training needs to continuously upskill the members of the WW CQ team.

At this level, the position has a greater degree of impact on the business results and responsibility for managing a group of professionals.

Performs other related duties as assigned by management.

Duties and responsibilities

  1. Digital and Data Analytics (20%)
  2. Leads QMS improvement projects (15%)
  3. KPIs and QSMR (15%)
  4. Team management and coordination (20%)
  5. ICQAs overall oversight and maintenance (5%)
  6. Conducts internal quality system audits and follow-up activities and supports ERC audits (5%)
  7. Performs other related duties as assigned by management (20%)

Qualifications

Minimum of 8 years of professional experience in quality assurance / regulatory, specific to working within the Medical Device industry or other GxP controlled environment

Minimum of 4 years of quality auditing experience in GMP areas is required

Expert knowledge of NCs/CAPAs, escalations and Field Actions activities in a highly regulated environment is required

Expert knowledge of Quality Agreements requirements is required

Experience supporting regulatory compliance audits is required

Expert knowledge, understanding and application of audit principles, concepts and practices related to regulated quality systems

Lead auditor certification (ASQ, BSI, etc) is preferred

Experience implementing and deploying new processes and/or systems is preferred

Experience with multiple global quality systems elements such as audits, Management Review, CAPA, non-conformance, change control and training is required

Excellent communication, organizational, negotiation, decision-making, critical-thinking and interpersonal skills

Fluent knowledge of English language

Good knowledge and experience in digital and data analytics is required

Project management experience including global cross functional projects is preferred

Experience and good understanding of J&J Quality Standards is preferred

Location & travel requirements.

The position is global then candidates from any locations are eligible. As the role is Global in nature periodic travels might be required

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong

Primary Location Europe/Middle East/Africa-Spain-Community of Madrid-Madrid

Other Locations Asia Pacific-China-Zhejiang-Hangzhou, NA-CA-Ontario-Toronto, Asia Pacific-Singapore-Singapore-Singapore, Latin America-Brazil-São Paulo-São Paulo, Europe/Middle East/Africa-Czech Republic-Prague-Prague, Europe/Middle East/Africa-United Kingdom-England-Wokingham, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux, NA-US-Florida-Jacksonville, Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Netherlands-Groningen-Groningen, Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem, Europe/Middle East/Africa-Ireland-Dublin-Dublin, NA-US-Puerto Rico-Anasco

Organization Johnson & Johnson, S.A

Job Function Customer/Commercial Quality

Req ID: W


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