Primary Role:
This individual will work in the Supplier Quality sub-group of the Shire Human Genetic Therapies Quality Assurance department. This unit oversees contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of Shire. This position is responsible for successful, timely completion of goals and objectives that strengthen the Quality organization and Shire. The position may require approximately up to 35% travel.
Responsibilities:
This position is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors, material suppliers to all applicable GMP & GDP standards. The individual may be responsible for, but is not limited to:
• Lead and perform batch disposition. Coordinate scheduling, prioritization and follow up with regulatory filing updates and associated change controls.
• Review and approve: batch records, specifications, deviations, CAPAs, and change controls. Leadership on implementation and revision is expected.
• Review, approve and lead deviations, CAPAs and change controls. May lead or support investigations and nonconformance reviews, upon management request.
• Support technology transfer, process scale-up, and process improvement projects. As the QA representative, leadership is required on relevant quality systems and filing updates.
• Enhance and maintain metrics for vendor performance and compliance. Seek improvement opportunities based on periodic trending.
• Oversee the external audit program. Lead external audits, effectively communicate outcomes and follow up on actions.
• Lead meetings and audits of suppliers (contractors) and effectively communicate.
• Participate with relevant regulatory filing updates and inspections.
• Support Quality testing of outsourced manufacturing including, but not limited to: COA approvals, OOS approvals and associated quality systems.
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
Requirements:
Education & Experience Requirements:
Essential:
• Bachelor’s degree in chemistry, biology or a related discipline
• 5-7 years Quality Assurance experience supporting the manufacture of drugs, biologics, or devices.
• Experience as a lead auditor or audit team member.
• Thorough understanding of quality systems and cGMPs.
• Interpersonal skills and professional skills to interact with contractors while representing Shire.
• Must be flexible.
• Must be able to travel.
• Must be able to prioritize and multitask in a stressful environment.
• Must be able to read, understand, speak, and write (print) legibly in English. desired:
• Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
• Experience working with contract manufacturing organizations.
• Experience interfacing with regulatory bodies or working on regulatory submissions.
• High level of professional competence. Preferably demonstrated by objective certification (e.g. ASQ Certified Quality Auditor or Engineer).
Key Skills and Competencies:
• Organization
• Critical thinking/ evaluation of process problems
• Data trending and evaluation
• Ability to multi-task in environment with changing priorities
• Strong work ethic
• Organization
• Proactively addressing compliance issues and assuming responsibility for compliance deficiencies.
• Actively leading “Lessons Learned” activities.
• Ability to develop gap analysis and action plans.
• Living the values is a basic expectation for all Shire employees. Shire expects all employees to 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.
Complexity and Problem Solving:
• Evaluation of batches to ensure there is no impact to safety, identity, strength, quality, or purity
• Evaluation of changes to regulatory filings and/or validated systems.
• Evaluation of manufacturing or operational issues for impact and communication to management.
• Impact of schedule changes to clinical and commercial supply.
Internal and External Contacts:
Internal
• Supply Chain/Global Logistics
• Contract Manufacturing
• Program Management
• Regulatory Affairs
• Quality Control
• Pharmaceutical and Analytical Development
• Materials Management (Warehouse, Planning, and Purchasing) External
• Contract Manufacturers
• Distributors
• Suppliers: Various raw material manufacturers and contract testing labs
Other Requirements:
• Ability to work during routine business hours
• Ability to travel approx. 35% (Domestic and International Travel)
Apply to Shire
