Senior Manager, QC Investigations and Training Compliance
Novato, CA
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 SummaryThe Sr. Manager of Quality Control Investigations and Training Compliance is responsible for managing the performance of the critical compliance functions of investigation and training execution. This role manages a group that assures these functions are operating in a state of compliance with all BioMarin standards and current industry and regulatory standards. The role also establishes the systems by which these compliance activities are executed in an organized and efficient manner. Investigations within the scope of this role are:o Environmental Monitoring Alert, Action, Adverse Trend investigations.o Laboratory Investigationso Deviation events.Training activities within the scope of this role includes:o Developing and maintaining appropriate training curricula.o Assuring personnel are properly trained and that the training is properly documented.o Streamlining training to remove redundant activities and provide the most relevant training to personnel.The scope covers both clinical programs and commercial products across various modalities. This position reports to the Quality Control Site Head and is a member of the Novato Site QC Leadership Team. The successful candidate ensures functional objectives are aligned with company goals and regulatory expectations.Role Responsibilities• Provide directives and manage the personnel to assure that Quality Control investigations are in a state of compliance with all BioMarin standards and current industry and regulatory standards.• Provide directives and manage the personnel to assure that Quality Control training is in a state of compliance with all BioMarin standards and current industry and regulatory standards. • Ensure appropriate resources are allocated and implemented for QC investigation and training compliance. • Develop and improve policies, procedures and business practices to maintain and/or enhance compliance status• Implement the concepts of Operational Excellence and deploy appropriate systems and processes to enable the efficient operation of a GMP laboratory supporting multiple platforms and modalities • The position effects continuous-improvement initiatives by:• Leading a team of professionals with specialized job functions addressing QC investigations and training.• Mapping and identifying metrics to monitor current business processes and identifying and implementing process improvements.• Building cross-functional workgroups and teams and facilitating identification of goals and delineation of responsibility.• Communicating systems improvements effectively to ensure efficient adoption• Documenting systems improvements in SOPs and policy documents• Represent the company at regulatory inspections and audits, and defend QC processes, laboratory practices and documentation systems.• Represent QC in cross-functional meetings and project teams.• Assures appropriate and aligned training for QC personnel and champion continuous improvement efforts as part of the overall Quality portfolio.• Identifies, prioritizes and sponsors the identification and execution of process improvement initiatives. Works alongside project managers from across the organization to drive additional process or capital initiatives that stem from the initial process improvement workshops. • Establishes efficient processes and systems to track and report status of initiatives including resources, projects, savings, etc. • Develops department strategy and budget. Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management• Other duties as assignedEducation Required• PhD with at least 4 years of experience in a relevant functional area • M.S. with at least 6 years of experience in a relevant functional area • B.S. with at least 8-10 years of experience in a relevant functional area (at least 2 years in Quality Control). Experience RequiredThe position requires:• At least five years in a cGMP laboratory, Quality Control experience preferred. • Demonstrate expertise with Quality Management Systems and Learning Management Systems.• Ability to work independently, managing projects and meeting established timelines. • Comfortable with managing the activities of other staff members. • Computer literacy is required. Experience with Laboratory Information Management systems (i.e., LIMS) is preferred. Supervisor ResponsibilityManagement of the Quality Control Investigations and Training Compliance staff.Competencies RequiredThe position requires:• Strong leadership skills• Well-developed organization skills with exact attention to details.• Strong deductive reasoning skills• Excellent written and verbal communication skills.Behavioral• Accountability• Achieving Excellence• Communication• Courage / Challenge• Develop Self & Others• Judgement• Reliability• TeamworkTechnical• GMP Acumen• Critical Thinking & Evaluation • Influencing • Organizational Awareness • Performance Management • Self-Knowledge Note: 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. 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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