Associate Director, Quality Planner
Novato, CA
Who We AreFor more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.Our CultureOur desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.BioMarin\u2019s 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\u2019s 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\u2019 lives.Role Responsibilities Work with various stakeholders to identify how to consistently quantify demand within QC and QA organizations\u00A0 Define a Process to ensure demand requirements are updated regularly\u00A0\u00A0 Have a month-on-month demand plan, for the long-term planning zone\u00A0\u00A0\u00A0 Build a capacity model, Graphical representation of capacity\u00A0vrs\u00A0demand, identify month on month what are the drivers for demand, identify where deltas exist.\u00A0\u00A0 Within this model incorporate the asks for project resources and support to ongoing business activities.\u00A0\u00A0 Host a monthly Quality Capacity Planning Meeting to determine what actions can be taken within the Quality group to reduce the deltas.\u00A0\u00A0 Establish process with key stakeholders from QA, Supply Chain, QC, manufacturing etc. to align the rolling look-ahead, Release Commitment dates, and plan QA/QC capacity accordingly.\u00A0\u00A0\u00A0\u00A0 Act as Quality Single Point of Contact (SPOC) for all Lot Release & testing Planning and Prioritization activities and provide guidance and clear direction to the functions as necessary to enable successful delivery of the plan.\u00A0\u00A0 Ensure that the planning and execution of QC testing, QA release meets the supply planning schedule requirements\u00A0\u00A0\u00A0 Implement batch tracking /monitoring for each step in the process, flagging any issues early and\u00A0communicate\u00A0to impacted groups.\u00A0\u00A0i.e.\u00A0if lead time is being missed by any party.\u00A0\u00A0 Prioritize QC Testing/Sampling/Batch Record Review/ Batch Release/ Label Implementation Planning etc. in alignment with Supply Chain Planning to ensure no stock outs, while level loading workflow versus available resources. Ensure data accuracy in Oracle (e.g.\u00A0Lot release lead times) for key planning parameters.\u00A0\u00A0 Maintain tracking files and highlight potential delays,\u00A0i.e.\u00A0OOS causing a lead time miss, working on CAPAs with partners to avoid issues re-occurring, etc.\u00A0\u00A0\u00A0 Manage the handoffs and communications with key stakeholders / functions to establish and maintain visibility, alignment and adherence to the plan.\u00A0\u00A0 Facilitate regular status update meetings with key stakeholders.\u00A0\u00A0 Support /drive improvement projects in line with business needs to optimize the Make, Assess, Release Run performance reports and calculate weekly and monthly metrics for site Quality performance\u00A0\u00A0\u00A0 Negotiate and manage SLAs with key customers as required.\u00A0\u00A0\u00A0 Support budget preparation and monitoring, capacity planning, calculation of batch numbers, monitoring spend versus budget, latest estimate etc.\u00A0\u202F\u00A0Education Required\u00A0B.S. with at least 6-10\u00A0years\u2019 experience\u00A0in a relevant functional area (at least 2 years in Quality Control and/or Quality Assurance).\u202F\u00A0Experience Required\u00A0 At least two years in a cGMP laboratory, Quality Control experience preferred.\u202F\u00A0 Operational Excellence (ex.Lean Six Sigma certification) experience preferred\u00A0 Ability to work independently, managing projects and meeting established timelines.\u202F\u00A0 Computer literacy is required.\u202F Experience with Information Management systems (i.e., LIMS, BINOCS,\u00A0PowerBI) is preferred.\u202F\u00A0\u00A0Competencies Required\u00A0Strong leadership skills\u00A0 Well-developed organization skills with attention to\u00A0details.\u00A0 Excellent written and verbal communication skills.\u00A0\u00A0Behavioral\u00A0 Accountability\u00A0 Achieving Excellence\u00A0 Communication\u00A0 Courage / Challenge\u00A0 Develop Self & Others\u00A0 Judgement\u00A0 Reliability\u00A0 Teamwork\u00A0Technical\u00A0 GMP Acumen\u00A0 Critical Thinking & Evaluation \u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F \u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u00A0\u00A0 Influencing\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F \u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u00A0\u00A0 Organizational Awareness\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F \u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u00A0\u00A0 Performance Management\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F \u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u00A0\u00A0'Self-Knowledge\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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.
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