Shire Quality Assurance Manager in Dublin, Ireland

JOB TITLE: QUALITY ASSURANCE MANAGER

JOB LOCATION: Dublin, Ireland

JOB DETAILS: Permanent, Full-time

ROLE SUMMARY

In relation to Shire Products and relevant wholesale license; the Quality Assurance Manager at Shire Pharmaceuticals Ireland Limited will have overall responsibility for ensuring that a quality management system is implemented and maintained in accordance with the Guidelines on Good Distribution Practice for medicinal product for human use (2013/C 343/01); Quality Assurance activities for Ireland: Assure Implementation, maintenance and advancement of a systematic and efficient local quality assurance system according to applicable local requirement and relevant global requirements:

  • Responsible for the Ireland region

  • Global and local interaction with internal and external parties will be required

  • Accountability as responsible person for pharmaceutical distribution activities

  • Primary contact for local health authorities. Own relationship /communication with the local GDP Authorities, and host External and Internal inspections in Ireland

  • Responsible for the execution of product launches in Ireland

  • Support wholesaling activities for Shire Products covered by SPIL WDA

JOB DUTIES & DESCRIPTION

In relation to Shire Products and relevant wholesale licenses;

The company has given authority to the Responsible Person to perform the required activities as outlined in EU GDP Guidelines

Responsible Person (RP) responsibilities include but are not limited to:

  • Ensuring that a quality management system is implemented and maintained;

  • Focusing on the management of authorised activities and the accuracy and quality of records;

  • Ensuring that initial and continuous training programmes are implemented and maintained;

  • Coordinating and promptly performing any recall operations for medicinal products;

  • Ensuring that relevant customer complaints are dealt with effectively;

  • Ensuring that suppliers and customers are approved;

  • Approving any subcontracted activities which may impact on GDP;

  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;

  • Keeping appropriate records of any delegated duties;

  • Deciding on the final disposition of returned, rejected, recalled or falsified products;

  • Approving any returns to saleable stock;

  • Ensuring that any additional requirements imposed on certain products by national law are adhered to

  • To write, review and approve SOPs as required

  • Reviewing and advising upon the company’s standard operating procedures in relation to the operation of the license

  • Overseeing audit of the quality system on a regular basis, tracking and assisting in the closure of Internal and External Audits

  • Implementation, execution and administration of CAPA’s as required

  • Ensure that accurate records, as required by the individual elements of the QMS, are kept and maintained in a secure manner

  • Assist the Supply Chain Organisation to ensure continuity of supply is maintained.

  • Support ongoing integration projects at Shire associated with Distribution and Supply

  • The RP shall be involved, as required, in communications with the HPRA with respect to activities as they apply to the Wholesale Distribution Authorisation.

  • The Responsible Person shall be contactable at all times and shall provide the HPRA with the appropriate contact details.

  • Is accountable for all quality KPIs for the country or country cluster as required

  • As an active member of Global QA Community, contribute to develop and strengthen global quality management systems, and provide flexible support to business both at the country level and global level.

  • Providing any other duties or giving such other advice properly associated with the duties of a Responsible Person under the terms of the License and Guidelines on Good Distribution Practice for medicinal product for human use (2013/C 343/01).

  • Support to Quality Lead and other RPs within the cluster

  • Ensure appropriate notification to HPRA for products in scope of OCABR process and appropriate tracking of their release are in line with appropriate timelines.

  • Ensure inspection readiness in market

  • Support ongoing integration projects at Shire associated with Distribution and Supply

  • Support to Quality Lead and other RPs within the cluster

EDUCATION & EXPERIENCE REQUIREMENTS

  • Qualification as responsible person for GDP (as applicable and required by country regulations)

  • Bachelor’s Degree in scientific discipline

  • Practical experience of at least 5 years in the Pharmaceutical Industry, a majority of which has been gained in a QM / QA environment. Supply Chain knowledge is beneficial.

  • Good knowledge of Pharmaceutical Quality Management systems

  • Experience in handling inspections from local authorities

  • Excellent knowledge of local GDP and Controlled Substances regulations, plus good awareness of other GMP\GDP requirements e.g. ICH, FDA

  • Experience of working with suppliers and customers

  • Experience in working in a global and matrix environment

KEY SKILLS & COMPETENCIES

  • Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team

  • Execute goals and objectives in a driven and a high performance culture, and as applicable with ability to achieve results with non-direct reports

  • Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders

  • Able to work with a great degree of autonomy, as part of a global virtual team

  • Able to work cross-functionally and cross-culturally, in a global business environment

  • Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed

  • Able to adapt to changes and positively respond to changes

  • Enthusiastic, resilient, dynamic, versatile. Display 'Can do' attitude

  • Good interpersonal and communication skills

  • Excellent verbal and writing skills and fluent in English and as applicable, local language is desired

COMPLEXITY & PROBLEM SOLVING

  • Strive to drives the business forward and look for practical and compliant solutions to issues.

  • Understands total potential impact and contributes significantly to the solution of simple or complex issues arising

  • Expected to work with a number of suppliers / products

  • Provide a positive and solution oriented environment

  • Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently

  • Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures

INTERNAL & EXTERNAL CONTACTS

  • Primary Internal Contacts:

  • Country Management(s)

  • Distribution and Supply Chain Quality

  • OpU Quality functions

  • Center Quality functions

  • Supply Chain

  • UK QA team

  • SPIL RP

  • Pharmacovigilance

  • Primary External Contacts:

  • Authorities

  • Pre-wholesalers

  • Distributor partners

  • Customers

  • External laboratories

OTHER JOB REQUIREMENTS

  • Travel required for Global meetings and/or auditing suppliers.

  • Travel to responsible countries is required for operation activities and for inspections.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.