Manager/Sr. Manager, External Quality Planner
Location Dublin, Ireland ApplyWho We Are
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.
SUMMARY DESCRIPTION
The Manager/Sr. Manager, External Quality Planner reports to the Director of QA CMO Operations and is responsible for oversight of processes to ensure on-time batch release for External Quality as per long range planning requirements.
The Manager/Sr. Manager, External Quality Planner reports to the Director of QA CMO Operations and is responsible for oversight of processes to ensure on-time batch release for External Quality as per long range planning requirements.
In addition, this role is responsible for alignment of Quality Capacity within the Supply Planning Cycle, including maintenance of associated master data. This role interacts with Senior level management to influence decision and policy making and participates in corporate development and improvement of systems and processes as required.
The role also plays a key role in ensuring effective communication and streamlined processes within the External Quality and GEO organization, particularly in the context of Make, Assess & Release.
This position will work closely with and serve as a business partner to External Quality functions, Global External Operations (GEO), Site Quality Functions (Novato and Shanbally Operations), and Supply Chain.
RESPONSIBILITIES
• Ensure that the long-range planning and execution of CMO release, incorporating QC testing, QA Batch Record Review and QP release, meet the supply planning schedule requirements.
• Support S&OP processes by aligning Quality Capacity requirements within the plan throughout planning cycles.
• Ensure data accuracy in ERP (e.g., Lot release lead times) for key Quality parameters.
• Primary Admin for BINOCS for External Quality with support from area specific admins
• Utilize tracking files and highlight potential delays regarding capacity concerns.
• Manage the handoffs and communications with key stakeholders / functions to establish and maintain visibility, alignment and adherence to the plan. (e.g., monthly report headlines, key initiatives update)
• Establish and maintain KPIs for External Quality. Run performance reports and calculate weekly and monthly metrics.
• Develop KPI Dashboard – Power BI
• Support External Quality Continuous Improvement efforts
• Enhance and Lead External Quality Tier 3 meeting
• Other duties as assigned
• Ensure that the long-range planning and execution of CMO release, incorporating QC testing, QA Batch Record Review and QP release, meet the supply planning schedule requirements.
• Support S&OP processes by aligning Quality Capacity requirements within the plan throughout planning cycles.
• Ensure data accuracy in ERP (e.g., Lot release lead times) for key Quality parameters.
• Primary Admin for BINOCS for External Quality with support from area specific admins
• Utilize tracking files and highlight potential delays regarding capacity concerns.
• Manage the handoffs and communications with key stakeholders / functions to establish and maintain visibility, alignment and adherence to the plan. (e.g., monthly report headlines, key initiatives update)
• Establish and maintain KPIs for External Quality. Run performance reports and calculate weekly and monthly metrics.
• Develop KPI Dashboard – Power BI
• Support External Quality Continuous Improvement efforts
• Enhance and Lead External Quality Tier 3 meeting
• Other duties as assigned
Supervision Received:
• Works autonomously on the accomplishment of agreed upon goals and objectives.
• Proactively identifies and reports discrepancies from normal practices or procedures to senior management, recommending and implementing plans for improvements.
• Works autonomously on the accomplishment of agreed upon goals and objectives.
• Proactively identifies and reports discrepancies from normal practices or procedures to senior management, recommending and implementing plans for improvements.
Expected area of competence:
• Resource planning alignment with strategic priorities.
• Influence the organization by communicating quality issues and decisions, which impact the business.
• Active participation to company business growth objectives for quality alignment.
• Identify and take advantage of opportunities to do something new and different, continuous improvement.
• Resource planning alignment with strategic priorities.
• Influence the organization by communicating quality issues and decisions, which impact the business.
• Active participation to company business growth objectives for quality alignment.
• Identify and take advantage of opportunities to do something new and different, continuous improvement.
Decision making:
• Establish operational objectives within the team.
• Be involved in developing, modifying, and executing company policies and procedures that affect quality control operations.
• Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Ensure budget schedules and performance requirements are met.
• Establish operational objectives within the team.
• Be involved in developing, modifying, and executing company policies and procedures that affect quality control operations.
• Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Ensure budget schedules and performance requirements are met.
EDUCATION
• Must possess a Bachelor's degree in Sciences, biotechnology, chemistry, microbiology or equivalent
• Advanced degree preferred.
• Advanced degree preferred.
EXPERIENCE
• 5 to 10+ years of experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
• Extensive knowledge and experience in pharmaceutical health care operations, quality control, quality assurance, and international regulations are essential.
• Proficient in cGMPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations.
• Proficiency with eQMS, LIMS, eCDMS and Office 365 preferred
• Extensive knowledge and experience in pharmaceutical health care operations, quality control, quality assurance, and international regulations are essential.
• Proficient in cGMPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations.
• Proficiency with eQMS, LIMS, eCDMS and Office 365 preferred
Range:
The range being broadcast for this role is at the Manager level. If the candidate's experience justifies Sr. Manager level, that will be considered and range reflected appropriately.
Equal Opportunity Employer/Veterans/Disabled
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.