Job Description
Who We Are For 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 Culture Our 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. The Quality Planner for Novato Site Quality reports to the Head of Quality for the Novato site, and is responsible for establishing, implementing and maintaining processes to ensure on-time testing & release per planning schedule requirements. In addition, this role is responsible for providing strong leadership, coordination and alignment between the key functions of QA, QC, manufacturing, Supply Chain, and the External Operations teams, to agree and deliver upon monthly commitment dates for batch release aligned with the Supply Plan and Quality Capacity. This role interacts with executive level management to influence decision and policy making and participates in corporate development and improvement of systems and processes as required.\u00A0\u00A0The purpose of the role is to bring transparency to, and provide an overview of, all lots planned for Quality testing & release at the different stages of the release process, such that a commitment date for testing & release is agreed monthly according to the capacity constraints of the Quality organization, and release priorities are aligned with the Supply Plan and key stakeholders. In addition, this role serves to embed a planning culture in our management of Quality testing & release activities and ensure that our priorities are based on a single source of truth, one valid plan and accurate data. Additionally, this role will serve as the connection from the site Quality team to our long-term Quality strategy, ensuring projects and initiatives are identified and supported to support future growth and improvement opportunities.\u00A0\u00A0Role Responsibilities\u00A0Establish process to determine long term demand, both from supply chain and strategic business demand.\u00A0\u00A0Work with various stakeholders to identify how to consistently quantify demand within QC and QA organizations\u00A0Define a Process to ensure demand requirements are updated regularly\u00A0\u00A0Have a month-on-month demand plan, for the long-term planning zone\u00A0\u00A0\u00A0Build a capacity model, Graphical representation of capacity vrs demand, identify month on month what are the drivers for demand, identify where deltas exist.\u00A0\u00A0Within this model incorporate the asks for project resources and support to ongoing business activities.\u00A0\u00A0Host a monthly Quality Capacity Planning Meeting to determine what actions can be taken within the Quality group to reduce the deltas.\u00A0\u00A0Host Establish a monthly Quality Capacity Planning Meeting forum with key stakeholders from QA, Supply Chain, JCMO, QC, manufacturing etc. to align the rolling look-ahead, agree Release Commitment dates, and plan QA/QC capacity accordingly.\u00A0\u00A0\u00A0\u00A0Act 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\u00A0Ensure that the planning and execution of QC testing, QA release meets the supply planning schedule requirements\u00A0\u00A0\u00A0Implement batch tracking /monitoring for each step in the process, flagging any issues early and communicate to impacted groups.\u00A0 i.e. if lead time is being missed by any party.\u00A0\u00A0Prioritize 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. Seek formal approval for changes to plan within the agreed time horizon and re-negotiate lot release dates with Supply Chain Planning when necessary.\u00A0\u00A0Ensure data accuracy in Oracle (e.g. Lot release lead times) for key planning parameters.\u00A0\u00A0Maintain tracking files and highlight potential delays, i.e. OOS causing a lead time miss, working on CAPAs with partners to avoid issues re-occurring, etc.\u00A0\u00A0\u00A0Manage the handoffs and communications with key stakeholders / functions to establish and maintain visibility, alignment and adherence to the plan.\u00A0\u00A0Facilitate regular status update meetings with key stakeholders.\u00A0\u00A0Support /drive improvement projects in line with business needs to optimize the Ready, Run, Release process.\u00A0\u00A0Run performance reports and calculate weekly and monthly metrics for site Quality performance\u00A0\u00A0\u00A0Negotiate and manage SLAs with key customers as required.\u00A0\u00A0\u00A0Support budget preparation and monitoring, capacity planning, calculation of batch numbers, monitoring spend versus budget, latest estimate etc. \u202F\u00A0\u00A0\u00A0\u00A0Education Required\u00A0B.S. with at least 6-10 years experience in a relevant functional area (at least 2 years in Quality Control and/or Quality Assurance).\u202F\u00A0\u00A0Experience Required\u00A0The position requires:\u00A0At least two years in a cGMP laboratory, Quality Control experience preferred.\u202F\u00A0Operational Excellence (ex.Lean Six Sigma certification) experience preferred\u00A0Ability to work independently, managing projects and meeting established timelines.\u202F\u00A0Computer literacy is required.\u202F Experience with Information Management systems (i.e., LIMS, BINOCS, PowerBI) is preferred.\u202F\u00A0\u00A0Competencies Required\u00A0The position requires:\u00A0Strong leadership skills\u00A0Well-developed organization skills with attention to details.\u00A0Excellent written and verbal communication skills.\u00A0\u00A0Behavioral\u00A0Accountability\u00A0Achieving Excellence\u00A0Communication\u00A0Courage / Challenge\u00A0Develop Self & Others\u00A0Judgement\u00A0Reliability\u00A0Teamwork\u00A0\u00A0Technical\u00A0GMP Acumen\u00A0Critical 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\u00A0Influencing\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\u00A0Organizational 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\u00A0Performance 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\u00A0Self-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 \u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u202F\u00A0\u00A0\u00A0Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.\u00A0 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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