Jazz Pharmaceuticals

Senior Quality Assurance Manager, Affiliates

IE-Dublin
2 months ago(10/5/2017 9:29 AM)
ID
2017-1278
# of Openings
1
Category
Manufacturing

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

Reporting to the Executive Director of Quality and Commercial Operations. Responsible for performing key Quality tasks in respect of Jazz  Affiliates. Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations, product development, IMP release and Affiliate Quality Operations as well as internal Quality Systems. 

Responsibilities : 

Responsible for developing and maintaining Quality Systems and Vendor Management activities at Jazz Affiliates to ensure that all operations are fully in compliance with current international standards for GXP and Codes of Practice for Marketing . Specific responsibility for developing and improving Quality Assurance compliance in Jazz Affiliates globally in order to comply with Jazz and Regulatory requirements.

Responsible for, but not limited to:
•    Develop, process map and maintain the Quality Management System, QMS, (i.e. Personnel, Documentation Control, Customer Complaints, Quality Defects, Deviation and Investigation Management, Product Recall, Local Self-Inspection, Vendor/Service Supplier Audits, Quality and Technical Agreements, Risk Management, Change Control, Annual Product Review and Management Review) and ensure that it is compliance with Jazz Policies, Procedures and National legislation.
•    Prepare for, co-ordinate, and manage HA Inspections at Affiliates, ensure any citations are addressed in a timely manner and are shared so that appropriate actions can be taken globally to ensure other Affiliates are not cited for the same deficiency. 
•    Notify Global QA about up-coming HA Inspections
•    Manage the Affiliates external audit programme (e.g. vendor, distributor or service supplier audits).
•    Manage the Affiliates’ self-inspection programme to ensure regular audits are performed to assess the effectiveness of the QMS.
•    Ensure that all non-compliances and deviations are documented and investigated by identifying root causes, and that the responsible area implements adequate CAPA.
•    Manage the Affiliate customer complaint system including promotional complaints. Ensure complaints are reviewed for trends and to assess effectiveness of corrective and preventive actions, CAPA’s.
•    Assist as appropriate to manage recalls at National level (local Market Responsible Person), assist QS to co-ordinate the recall procedure and ensure the system is tested regularly.
•    Ensure Technical Quality Agreements are in place with all applicable contractors, distributors and service providers.
•    Ensure compliance of validation requirements for Affiliate processes and systems. Review and approve master validation plans and protocols.
•    Manage the review and approval of functional procedures, GXP procedures and master documents.
•    Support Affiliate GXP Training Policy & Programmes including documentation of same, review of effectiveness of the programme and refresher training.
•    Provide central advice, guidance and training to Affiliate employees on Jazz Policies, Procedures and any compliance or GXP related issues.
•    Investigate problems associated with Quality Systems, identify gaps in current practices and follow up recommendations.
•    Ensure promotional material is reviewed for compliance with Codes of Practice and Marketing Authorisations.
•    Ensure a system of change control is in place regarding SmPC changes, legislation or Group Policies, Guidelines and SOP’s.
•    Ensure potential risks to the company are managed in an appropriate manner. Update and implement elements of local Risk Management Plans as appropriate.
•    Identify areas for Continuous Improvement.
•    Ensure Annual Product Quality Reviews (APQR’s) are reviewed.
•    Keep up to date with the latest legislation and development from the regulatory authorities, GXP requirements, Marketing Code of Practice and best practices.

Other Responsibilities:
•    Work closely with other members of Quality and Commercial Operations group to ensure delivery of key objectives and timelines
•    Work directly with other key Company departments to ensure compliance and productive working relationships.
•    Assist with troubleshooting quality issues at Affiliate sites.
•    Integrate, contribute, and/or lead cross-functional project teams as required.  Support projects schedules as required.
•    Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.


Professional Competencies:
•    Bachelor’s degree in chemistry, biology or a related discipline
•    Significant experience (3-8 years) working in Quality Systems, Quality Control, Affiliate support, GXPs and GXP Training, finished product pharmaceuticals / biologics, and /or manufacturing areas
•    Experience with the following extremely desirable: GDP Responsible Person role, Computer system/software validation, Business Continuity Planning and Risk Assessments
•    Experience with self-inspection, third party vendor auditing, deviation investigations, change control and complaints
•    Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
•    Experience in hosting HA Inspections
•    Experience interfacing with regulatory bodies or working on regulatory submissions

Personal Competencies: 

•    Highly organised, with exceptional time management and prioritisation
•    Critical thinking and evaluation of process problems
•    Excellent verbal and written communication skills
•    Patient and results focused
•    Good Leader and highly motivated.
•    Collaborative team player
•    Strong work ethic with a flexible and adaptable approach
 

Jazz Pharmaceuticals is an Equal Opportunity Employer.

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