Associate Director Quality – Pharm Operations & Centre of Excellence Job

Date: Apr 11, 2019

Location: Tipperary, IE

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Requisition ID: QUA008674


MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.






Associate Director Quality – Pharm Operations & Centre of Excellence


 

MSD Ireland (Ballydine)

 

Are you ready to Invent, Impact, Inspire?

 

Join MSD and shape the future of healthcare in Ireland

 







INTRODUCTION

 

At MSD Ireland, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.




 

THE COMPANY

 

MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.


We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.


In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.


With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.


 



MSD BALLYDINE



MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.


 

Our highly-skilled local workforce of 500 employees is now leading the way in the development of new medicines, including MSD’s treatment for hepatitis C, which is being manufactured in Tipperary for patients around the world.


MSD Ballydine’s existing portfolio and future pipeline offers team members the opportunity to operate at the cutting-edge of science and technology, and develop new treatments that positively impact patients across the globe.


 



Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.





& SPECIFIC OBJECTIVES

 



  • Reporting to the Director of Quality, the Quality Leader Oral Solid Dose IPT and Quality Systems CoE is a member of the site quality leadership team.

  • The Quality Leader is a self directed, decision maker who is responsible for the management and oversight of the Quality Management Systems in the Drug Substance and Drug Product facilities and for the achieving the Quality deliverables in the Drug Product Integrated Process Teams (IPTs).

  • The Quality Leader leads the QP team to ensure all Oral Solid Dose intermediate and finished product are released in compliance with GMP.

  • The Quality Leader leads and develops the Quality Systems and Quality Drug Product teams, ensuring that the site meets all Manufacturer’s Licence requirements for clinical and commercial production and is audit ready for both customers and agency inspections.

  • The role includes participation (as representative of MSD) in national quality organisations, staying abreast of regulatory developments, communication of such trends and developments to the Ballydine site and recommending appropriate action plans.

  • The Quality Leader may delegate for the Site Quality Director.


 



POSITION RESPONSIBILITIES

 



  • Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance.

  • Team Leadership: The Quality Leader is accountable for the development and performance of the Qualified Person team, Senior Quality Assurance Specialists and Quality Assurance Specialists in the COE and IPT teams.

  • Responsible for the continuous improvement of the site quality management systems.


 

Quality Systems CoE Principal Accountabilities:

Lead the Quality Systems COE team to ensure timely and effective completion of the Quality Systems core functions, including;




  • Quality Council System and Site Compliance Plan Management

  • Creation, review and approval of Site Quality documentation including; Site Master File, Validation Master Plan, policies and procedures.

  • MAH Licence maintenance and support for product filings

  • Quality Agreement System Management

  • Annual Review System Management

  • Supplier and Customer complaints System Management

  • Quality SME for Process, Cleaning, Water and Equipment Validation

  • Quality SME for Change Control (Process / Analytical / Supplier)


 

IPT Drug Product Principal Accountabilities:

Lead the Drug Product QP and Quality Specialist team to ensure timely and effective completion of the Quality IPT core functions, including;




  • Production support and quality compliance insight and guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.

  • Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals.


 

REPORTING STRUCTURE

 

The position reports to the the Quality Director


Qualifications




QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS


 



General



  • A minimum of 5 year experience in the Pharma regulated industry with Quality leadership experience

  • Demonstrated Continuous Improvement mindset and capabilities

  • Experienced in aligning individuals and teams to business objectives


 

Technical



  • Detailed knowledge of Pharmaceutical GMP and Regulatory expectations

  • Oral Solid Dose manufacturing processes

  • Validation

  • Auditing




People



  • Demonstrated success in managing a team in a pharmaceutical production environment

  • Highly developed people leadership and development skills 


 

Education



  • Degree or post graduate qualification in Science, Pharma or Engineering field

  • Qualified Person qualified (advantageous)


 



So, if you are ready to:

 

INVENT solutions to meet unmet healthcare needs

 

IMPACT the future by joining MSD, one of the world’s leading healthcare companies


 

INSPIRE your team to reach their full potential and push the boundaries of science and technology


 



Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means. 





Job: Quality GMP Related
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Operations Manager, Manager, Engineer, Healthcare, Operations, Management, Engineering

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