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Title:  Quality Compliance Manager (FTC)

Requisition ID:  37083
Date:  Oct 9, 2021
Location: 

Dublin, Leinster, IE

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Summary:

Responsibility for compliance with the quality and regulatory requirements for combination medicinal and device products assembled and packed by West CM (Dublin). This role is also responsible for overseeing the compiling of technical and quality documents in support of submissions to the relevant authorities, for obtaining and maintaining the required medicinal product manufacturing authorisations. Reports directly to the Quality Manager.

                                                 

Requirements:

  • Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent with at least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
  • Knowledge of and experience in setting up and maintaining a QMS which meets the legislative requirement of human medicines and medical devices in the EU and USA and the ISO13485 standard.
  • Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971
  • Experience of hosting regulatory audits from either the European or US authorities. 
  • Accredited lead auditor against recognised quality standards in support of internal and supplier audits
  • Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
  • Must have excellent written and verbal communication skills.

      

Essential Duties and Responsibilities:

  • Reporting to the Quality Manager of West CM (Dublin), this role will be responsible for the upgrading and maintaining of West CM (Dublin)’s quality systems to meet the requirements of the European and US Medicinal Product and medical device requirement, this includes the establishment, maintenance and continuous improvement of West CM (Dublin)’s quality systems, procedures and policies.
  • Manage the Quality Compliance team, 1:1 meetings and Training & Development Plan for Reports
  • Provide regulatory guidance to the business including regulatory training, keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact to West CM (Dublin) and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions. Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops.  Monitor local Regulatory Environment and feed-back to relevant stakeholders
  • Liaise with Customers and regulatory agencies on behalf of West CM (Dublin).
  • Supply Chain QA responsible for the review and approval of all Suppliers on the AVL and their ongoing control through Supplier Corrective Action Report management, vendor rating and audit management.
  • Develop, lead and maintain a comprehensive audit readiness program to ensure internal and external compliance
  • Drive standardization of West CM (Dublin) QMS in line with our parent company West Pharmaceutical Services
  • Develop reports / presentations on the status of the compliance program for West CM (Dublin) senior management team and the wider West Pharmaceutical Services colleagues.
  • Embed QMS management principles in the organisation & drive continuous improvement
  • Liaise with the QP on performance of the QMS and emerging quality trends and risks.
  • Conduct various trend analyses to identify short and long-range patterns so that recommendations can be made in order to effect continuous improvement necessary to satisfy customer requirements and drive improvements of West CM (Dublin) QMS
  • Work closely with the NPI and Operations Department to ensure that programs are introduced to West in a manner that complies with the appropriate regulatory requirements, customer specification and consistent with West Quality Management Systems (QMS)
  • Lead continuous improvement initiatives to ‘challenge’ the quality systems processes with respect to compliance / value add.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all site Environmental, Health and Safety requirements, training and regulations.
  • Compliance to all local site company policies, procedures and corporate policies.
  • Perform additional duties at the request of the direct supervisor.

 

 

Delegation of Duties:

 

When absent from the site, duties and responsibilities will be delegated to the following designates

  • QCM Approval on eg Supplier Classification and Assessments; KPI reporting. Audit Lead, Audit Tracking
    • Quality Program Lead

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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