Description
My Client, a Dublin based pharmaceutical Company are seeking Senior Quality Manager to Joined there team.Senior Manager Quality Assurance - Audit and compliance
Key Responsibilities Include;
- Oversee and maintain site inspection readiness program and Quality Management review processes.
- Host inspections (self-inspection and regulatory/corporate inspections).
- Oversee and maintain Supplier Quality Management process, Complaint and Self Inspection processes.
- Manage inspection outcomes, including inspection response compilation and tracking.
- Oversee and implement Quality Agreements relating to area of responsibility
- Challenge current procedures and practices to afford optimisation and further development of existing quality standards and overall compliance.
- Keep abreast of regulatory initiatives and new guidance/requirements
- Lead and mentor Quality Assurance team to challenge the status quo and realise improvement opportunities
- Collaborate with key internal and external stakeholders including manufacturing, regulatory affairs, Engineering, Development, Supply Chain, Automation and IS teams.
- Involvement in key systems, including change control, Non-Conformance, Disposition, Manufacturing procedures/processes, Validation.
- Other duties as assigned by the Quality Director
Leadership Responsibilities
- Mentor, coach, challenge and develop Quality Auditing/Compliance Team whilst serving as a role model.
- Individual goal setting and performance reviews.
- Ensure compliance with all legal and business requirements, Amgen policies and practices.
- Identification and communication of risk in area of responsibility.
Basic Qualifications
- Bachelor's degree and 8 years of directly related experience
Preferred Qualifications
- Background in Biological or Sterile manufacturing
- Well rounded experience in quality assurance including deviation management, validation, disposition, change control and auditing disciplines.
- Proven track record in regulatory inspection hosting and general engagement.
- Good technical skills and excellent interpersonal skills including strong verbal and written communication skills.
- Degree educated with a minimum of 5 years supervisory experience
- Strong communication, relationship building, leadership and mentoring skills
- Proven ability to manage and deliver results in a highly fluid, interactive matrix environment
If you are interest in this great opportunity please contact me Anna Mooney or apply below with an up to date CV.