Shire QA Manager in Dublin, Ireland

This individual will work in the QA Operations External Bio DS & DP sub-group of the Shire Pharmaceuticals Ireland Quality Assurance department. This unit oversees Qualified Person function, contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of Shire. This individual will be responsible for the QA management of EU contract manufactures, suppliers and test labs as applicable. This position will not have direct reports.

The position may require up to 15% travel.

Responsibilities:

This position is responsible for the management & control of EU contract manufactures, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP.

This individual will receive assignments in the form of goals.

The individual will be responsible for, but is not limited to:

• Responsible for QA Oversight of CMOs, Suppliers, QC Labs.

• Responsible for the compliant day to day management of CMOs / CTLs & resolution of all quality related issues.

• Leading meetings with external parties and representing Shire in a professional manner.

• Attendance at all weekly/ monthly and quarterly CMO / CTL meetings.

• Represent the Quality Function at BRMs

• Represent management in meetings and cross functional teams.

• QA support and management approval of all CMO/ CTL / Shire documentation.

• Development & assessment of quality metrics, CMO trending, KPIs and reports. Responsible to recommend actions as a result of such reviews / reports.

• Management of critical issues and timely resolution, developing solutions to complex problems.

• Proactive monitoring the performance of CMOs / CTL & suppliers to ensure that they remain in a state of control & implementing necessary improvements.

• Leading, reviewing and approval of deviations, change controls which are related to CMO / CTL management.

• Manager oversight and approval on all applicable quality systems pertaining to CMO / CTL management including but not limited to Deviations, Change Controls, CAPAs.

• Leading or supporting CMO / CTL / Quality projects

• Supporting audits (external)

• Support internal and regulatory agency inspections at Shire

• Analysis of CMO / CTL management processes, development of quality improvement plans and continuous improvement.

• Update and compliant management of CMO / CTL TQAs to ensure agreements are current and within date.

• Review and approval of CMO / CTL Annual Product Quality Reviews

• Roll out of training on QA procedures

• Support validation activities related to CMO’s/ CTL’s as required

• Support investigations into complaints as required

• Support product launches activities associated with CMO’s/CTL’s/ Suppliers

• Providing escalation, weekly updates, reports and statistics to management as required.

Education & Experience Requirements:

Essential:

• Minimum Bachelor’s degree in pharmacy, chemistry, biology or a related discipline.

• 8 to 12 years experience working in a QA role in the pharmaceutical industry.

• Thorough understanding of quality systems, cGMPs, GDPs.

• Experience with Aseptic/ Sterile Processing/Tabletting

• Excellent interpersonal skills and professional skills

• Must be flexible and comfortable with ambiguity in a “start up” environment

• Must be able to prioritize and multitask in an environment with changing priorities.

• Must be able to travel up to 15 %

• Must be able to read, understand, speak and write legibly in English.

Desired:

• Advanced degree

• Project management/ Lean / OE experience

• Experience working with multiple sites/ locations

• Experience working with contract manufacturing

• Experience interfacing with regulatory bodies or working on regulatory submissions

• Lead Auditor

• Experience with pre-filled syringes

Key Skills, Abilities, and Competencies:

• Organization

• Strong communication skills, to establish rapport and develop relationships with all key stakeholders: suppliers, customers and colleagues

• Effective time management and prioritization

• Responsible for establishing accountability, timelines and goals.

• Critical thinking/ evaluation of process problems

• Strong work ethic

• Ability to work with / motivate a team towards a common goal, to gain cooperation.

• Data trending and evaluation

• Ability to Multitask

• Proactively addressing compliance issues and assuming responsibility for compliance deficiencies

• Ability and experience to develop gap analysis and action plans.

• Living the values at Shire is a basic expectation for all Shire employees. Shire expects all employees for live the BRAVE values:

• Build on Integrity: Act with integrity in all you do. Be forth right in a way that builds sustained relationships. Demonstrate respect for the individual, diversity and the environment

• Risk a “Risk”: Believe in your convictions; anything is possible! Take measured risks and create innovative solutions that make a difference.

• Act on the Needs of Patients: With relentless dedication, serve our patients in everything you do. Create a quality customer experience for those you interact with.

• Vie to Be Better Than Yesterday: Demonstrate a true sense of urgency and don't make great ideas wait. Make progress everyday to avoid the complacency that prior success may bring.

• Exemplify Trust & Openness: Trust your colleagues and draw on their input for better outcomes. Collaborate across boundaries and geographies. Build openness through teamwork and focus on tackling business challenges.

Other Job Requirements:

• Ability to work during business hours but be flexible to cover US business hours.

Ability to travel approx. 15 % (not domestic)

About Shire:

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.

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.