Associate Director, Quality Planner

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 – 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’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.

Role Responsibilities

• Work with various stakeholders to identify how to consistently quantify demand within QC and QA organizations
• Define a Process to ensure demand requirements are updated regularly
• Have a month-on-month demand plan, for the long-term planning zone
• Build a capacity model, Graphical representation of capacity vrs demand, identify month on month what are the drivers for demand, identify where deltas exist.
• Within this model incorporate the asks for project resources and support to ongoing business activities.
• Host a monthly Quality Capacity Planning Meeting to determine what actions can be taken within the Quality group to reduce the deltas.
• 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.
• 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.
• Ensure that the planning and execution of QC testing, QA release meets the supply planning schedule requirements
• Implement batch tracking /monitoring for each step in the process, flagging any issues early and communicate to impacted groups. i.e. if lead time is being missed by any party.
• 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. Lot release lead times) for key planning parameters.
• Maintain 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.
• Manage the handoffs and communications with key stakeholders / functions to establish and maintain visibility, alignment and adherence to the plan.
• Facilitate regular status update meetings with key stakeholders.
• 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
• Negotiate and manage SLAs with key customers as required.
• Support budget preparation and monitoring, capacity planning, calculation of batch numbers, monitoring spend versus budget, latest estimate etc.

Education Required

• B.S. with at least 6-10 years’ experience in a relevant functional area (at least 2 years in Quality Control and/or Quality Assurance).

Experience Required

• At least two years in a cGMP laboratory, Quality Control experience preferred.
• Operational Excellence (ex.Lean Six Sigma certification) experience preferred
• Ability to work independently, managing projects and meeting established timelines.
• Computer literacy is required. Experience with Information Management systems (i.e., LIMS, BINOCS, PowerBI) is preferred.

Competencies Required

Strong leadership skills

• Well-developed organization skills with attention to details.
• Excellent written and verbal communication skills.

Behavioral

• Accountability
• Achieving Excellence
• Communication
• Courage / Challenge
• Develop Self & Others
• Judgement
• Reliability
• Teamwork

Technical

• GMP Acumen
• Critical Thinking & Evaluation
• Influencing
• Organizational Awareness
• Performance Management
• 'Self-Knowledge

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.

In the U.S., the salary range for this position is $ 136,700 to $ 205,100 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.