Quality Project Lead

Quality Project Lead (12-month contract) Dublin, Grange Castle - Hybrid JOB SUMMARY

Position is a single point of accountability to drive an end to end approach to the product across the network by assuring consistency in achieving product quality and compliance across multiple manufacturing sites and global markets. The role will provide coordination and leadership for cross-site quality and business processes and activities associated with the assigned portfolio to support supply targets.

A knowledge of the EU Regulations, cGMPs, GDP's and government regulations for pharmaceutical products globally including FDA/EU GMP requirements impacting manufacturing operations.

In addition to cGMP's, the role requires a demonstrated knowledge of compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.

MAIN AREA'S OF RESPONSIBILITY / ACCOUNTABILITIES

• Drive alignment of Quality strategy with overall Product life cycle to ensure by working with key stakeholders. Identify quality & compliance risks and drive mitigation strategies.
• Escalate critical issues with potential quality, compliance or supply impact as needed and drive resolution. Provide technical inputs to evaluate investigations, product and process issues. Provide input to Regulatory strategy development and guidance for regulatory conformance.
• Implement/Lead/Sponsor/Participate in cross site forums at a global level e.g. change control, specification review, stability.
• Recommend/Lead/Support Continuous Improvement projects.
• Monitor and/or provide input for Global Product Performance and Compliance of key product performance metrics as required.
• Participation/Leadership of global quality projects at the discretion of quality leadership.

KEY PERFORMANCE INDICATORS (KPI)

• Product Launch support to meet assigned timelines.
• Technical Transfer support to meet assigned timelines.
• Inputs to Risk Assessments/Risk Management.
• Lead/Drive Transformation and Continuous Improvement Projects to agreed milestones.
• Facilitate resolution of complex issues to ensure supply continuity that includes inputs into:
  • Deviations/Non-conformance Management
  • Complaints and Market actions
  • Change Control
  • CAPA and MCDP CAPA system
  • Regulatory inspections, audits, and self-audits
  • Vendor management

QUALIFICATIONS Level of Education

• University degree in Pharmacy, Chemistry, Biotechnology, Industrial Engineering, Automation, Biology, Medicine or related scientific field.

Experience

• 10 years' experience in the pharmaceutical industry with significant experience in pharmaceuticals and/or biopharmaceuticals and 5 years of robust site Quality management experience.
• Proven leadership skills and ability to involve several levels of an organization to successfully meet the objectives.

Languages

• English, fluent (written & spoken).

Computer Skills

• Proficiency in use of MS Office and key enterprise systems e.g. PLA, Veeva-Vault platform, EDMS, SAP.

COMPETENCIES - PERSONAL CAPABILITIES

• Knowledge of and adhere to cGMP, GDP, DI and EHS requirements.
• Knowledge of the EU/FDA Regulations, cGMPs and government regulations for pharmaceutical and biopharmaceutical products.
• Awareness of inspectional trends, industry quality assurance practices and systems.
• Problem-solving orientation.
• Networking skills.
• People management.
• Collaboration and Communication skills.
• Proactivity and best practice developer.
• Ability to work independently, as well as a member of team.
• Ability to analyses and utilize information.
• Ability to think creatively.
• Ability to learn constantly.
• Flexibility.
• Time management.
• Leading, Training and Mentoring skills.
• IMEX.
• Digital literacy skills.