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Manager, External Quality Planner

Employer
BioMarin Pharmaceutical Inc.
Location
Working from Home
Start date
May 20, 2024

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details



The 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 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. 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. 
 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. EDUCATION•    Must possess a Bachelor's degree in Sciences, biotechnology, chemistry, microbiology or equivalent
•    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 Salary Range:The advertised salary range for this position is set at the Manager level. If the candidate's experience justifies Sr. Manager level, the salary range and compensation components will be adjusted accordantly. 
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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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