Commercial Quality Senior Associate - 2406184239W

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 https://www.jnj.com/

J&J Innovative Medicine is recruiting for a Commercial Quality Senior Associate to be located in UK or Ireland.

The Commercial Quality Senior Associate works in the Commercial Quality Team UK and Ireland, which is part of the EMEA Commercial Quality Organisation. We are looking for an experienced Senior QMS Associate to join our team on a permanent basis reporting into the Quality Head UK. Working closely in a pro-active team you will support the Company in ensuring the highest standards of Quality Assurance and Compliance to Pharmaceutical regulations.

Duties and responsibilities

Pharmaceutical Environment’s Regulations

• Compliance with pharmaceutical sector legislation for all the technical-administrative activities of the company

• Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP requirements for UK and Ireland

• Implementing and verifying the technical-administrative completeness of documentation

Key Responsibilities:

Quality Management

Support the business units in terms of quality management and the resolution and communication of non-conformances. Maintain and implement the Quality system. Collaborate with internal and external partners to provide input to new projects and concepts.

Procedures

Lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity

the business units in terms of quality management and the resolution and communication of non-conformances. Maintain and implement the Quality system. Collaborate with internal and external partners to provide input to new projects and concepts.

Inspections / Audits

Assist in the management and follow-up services for local authority inspections. Support and conduct local internal and external quality audits.

Quality activities

Monitor the Quality System performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals. Support the Quality Head with monitoring and oversight of compilation of metrics where required. Ensure appropriate management of the preparation, execution and follow up of non-conformances and CAPAs related to GxP. Provide input to the Quality Head for the bi-annual Quality System Management Review for CQ.

Training

Support the continuous training programs ensuring they are maintained to guarantee appropriate competence and experience as well as knowledge of and training in GDP for the team and internal partners.

Continuous Improvement / Projects

Drive continuous improvement for the processes accountable for

Drive / participate to local / regional / Global projects

Professional Development

Training Record maintenance; constant update on legislations and Company’s requirements

Relations

Internal: All Company functions, Local/EMEA/Global Quality organizations, Functional stakeholders as required

External: Health Authorities, Home Office, External Certification Bodies as required

Qualifications

Qualifications and Experience

Life science degree or pharmacy technician qualification or equivalent qualification / experience in pharmaceutical regulations and processes.

Experience and Skills:

• Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position and experience with external regulatory bodies

• Self starter, ability to interpret data and present outcomes

• Excellent interpersonal and teamwork skills

• Demonstrated ability to organize and prioritize workload

• Enjoys working to multiple deadlines in a multifaceted and fast-paced team environment

• Strong technical writing, verbal communication, and problem-solving skills

• Quality Systems experience or other relevant experience including Quality Compliance.

• Computer literate with expert knowledge of Quality database systems

• Strong analytical skills

• External Body Qualification/Certification as Internal Auditor is preferred title

• Up to date knowledge of relevant pharmaceutical legislation and GMP/GDP. Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in UK are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Other Locations Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Ireland-Dublin-Dublin

Organization Janssen Cilag Ltd. (7360)

Job Function Customer/Commercial Quality

Req ID: 2406184239W