QA Packaging Team Lead
Hiring Manager: Samantha Duffy ([email protected])
Description
QA Packaging Team Lead - Shanbally, Ringaskiddy, Cork - Onsite
Closing date: 25th October 2024
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. 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.
BioMarin is a high-performing, team-based organization, 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.
Reporting to the QA Packaging Manager, the primary role of the QA Packaging Operations Team Lead is to manage the daily QA Packaging Operation; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met.
It is expected the QA Packaging Team Lead will develop a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant release of Finished goods. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.
Key Responsibilities:
• People Management for a Team of Quality Associates, including performance discussions, 1:1s and Development Conversations
• Coach, mentor and train team on processes, on appropriate way to analyze and respond to escalations, on use of operational excellence tools and on high performance team behaviors
• Lead and support the QA packaging team to ensure delivery of the Release Schedule while at all times striving for continuous improvement of our processes
• 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.
• Review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies.
• Assist in troubleshooting and facilitate appropriate cross functional discussions in order to come to solutions with an agreed path forward
• Represent the Quality Group as necessary at critical Meetings (E.g S&OE, Operations Meetings, Release Meetings etc.)
• Responsible for departments Key Performance Indicators (E.g. Lead Time) & departments training records and training plans.
• Lead/participate within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
• 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.
• root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues.
• Drive pre-approval Regulatory Inspection readiness within the team to ensure regulatory approvals are obtained.
QUALIFICATIONS & EXPERIENCE
• 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.
• Past experience and demonstrated ability in successfully leading and influencing team performance in a high-performance team is strongly preferred.
• Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
• Track record of embedding a strong Quality culture.
• 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 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.
DESIRED:
• 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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.