Senior QA AssociateLocation Cork, Ireland Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
Having just obtained approval to establish internal Sterile Drug Product Filling operations at the Shanbally site, we at BioMarin are now looking to commence hiring for key technical and leadership positions. Initially these roles will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.
BioMarin is a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
With the growth and expansion of operations at the Shanbally facility, this role (which reports to the QA Operations Manager) will provide QA support for the start-up of the Drug product facility as well as supporting new product introductions, introduction of new automation platforms on site (MES) and other expansion activities. This role will also provide QA support to related to drug substance and/or Secondary Packaging Operations, including batch release, as required.
The successful candidate will also have proven capability in promoting Quality across cross-functional teams, to deliver on-time high quality processes and products, whilst ensuring continuous process improvement.
- Provide Quality direction and oversight of the site expansion/start-up activities, technical transfers, routine GMP operations, and continuous improvement
- Provide Quality input to and approval of deviations, CAPAs, Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
- Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies.
- QA support to related drug substance and secondary Packaging Operations.
- Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
- Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
- Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
- Pro-actively identifies compliance risks and takes appropriate preventative actions.
- Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues.
- Ensure high level of Quality / cGMP Awareness in the operational teams on site.
- Lead Area GMP Certification Activities.
- Support pre-approval Regulatory Inspection readiness to ensure regulatory approvals are obtained.
- Support all Quality Assurance elements needed to facilitate new product launches.
- Provide coaching/mentoring to more junior staff in the QA team
- Support permanent inspection readiness on site
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
- Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
- Demonstrated experience in Sterile Drug Product Filling and start-up of same, secondary packaging and/or drug substance operations for biological products.
- Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
- Demonstrates strong knowledge of FDA / EMEA regulations/standards and quality systems as well as industry trends and standards.
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
- Strong organizational skills, including ability to follow assignments through to completion.
- Proficiency in PC skills such as Excel, Word, PowerPoint.
- Proven decision making capability with full accountability and responsibility.
- Demonstrated coaching skills.
- Excellent written and verbal communication skills.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
- Experience in Sterile Drug Product Filling and start-up of same.
- Experience in drug substance and secondary packaging operations for biological products
- Evidence of Continuous Professional Development.
- Evidence of Validation knowledge/experience.
- MES experience.
- Good knowledge of Lean / Continuous Improvement practices and root cause analysis.
- QP qualification (obtained or in progress)
- Always focused on the patient and customer needs.
- Resilient profile with the ability to deliver in a challenging environment.
- Ability to engage and manage multiple stakeholders to achieve the objective.
- Curious with learning agility.
- Operationally excellent, with attention to detail.
- Organised with systematic approach to prioritisation.
- Process orientated to achieve the business objective.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.