Director, External Quality, QA Operations
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.
The successful candidate for the Quality Systems role is a highly motivated technically knowledgeable leader with proven abilities to support quality assurance activities across external business partners for Technical Operations (TOPS). The candidate is responsible for the establishment and execution of the quality management system (QMS) framework with key customers and stakeholders, and for leading and delivering business excellence across all areas of the External Quality Organization.
This role will include responsibility for delivering improvements for the Quality team, leading and supporting the successful introduction of functional initiatives, and the optimization of systems and processes across Quality operations within the team.
In addition, the Quality Systems role act as the functional subject matter expert for department projects, is accountable for functional deployment of quality systems for the site, will monitor and improve QMS performance, act as owner of key quality governance processes, and is accountable for supporting cross functional teams in completing projects which add value to the External Quality Organization and to the overall BioMarin Organization.
Success in the position requires a thorough knowledge and experience of the BioMarin operation, the role and reach of the Quality organization, and a strong understanding of the processes and systems that are deployed by the Quality Team today.
The successful candidate will strengthen the Quality culture and ensure the manufactured product meets all company standards and government regulations. This leader will develop a high performing team and provides leadership and guidance to the organization. The role would champion continuous improvement to reduce variability in production and to maintain high quality product.
This position requires a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods and understanding of the international regulatory landscape. Improvement targets include, but are not limited to lot disposition, technology transfer, labelling processes, and management of quality agreements with external parties.
The Quality Systems role will report to the External Quality Site Head. This position will sit on the External Quality Leadership Team
Travel of 10% may be required.
- Direct activities within the External Quality Organization to ensure the deployment of the QMS is fit for purpose regarding external business partners.
- Lead and engage the site quality review team (SQRT) process to ensure site regulatory compliance, and identify opportunities for continual improvement of products, processes and the quality system itself.
- Facilitate various Material Review Boards (e.g., MRB, RMAB, GDPMR) to support product or material disposition decisions.
- Notify Senior Management of significant quality or regulatory issues that may impact product quality or regulatory compliance in a timely and succinct manner.
- Support overall Quality objectives and long-range goals.
- Manage development and performance of direct reports in appropriate ways that ensure they enjoy their career at BioMarin and are in the right role to achieve organizational and department goals with a productive environment.
- Coach and develop staff by providing an environment that encourages ongoing personal and professional growth.
- Manage and ensure the setting of realistic development goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.
- Prioritize, direct, and participate in continuous improvement initiatives.
- Perform any other tasks as requested by Senior Management to support Quality oversight activities.
- Manage the QMS intake processes for the External Quality team and GEO Site.
- Work with the Global Quality Systems team to optimize the use of QMS data to improve quality processes.
- Develop or enhance the metrics which allow the team to track and measure its contribution across all areas of its operation.
- Lead the challenge of delivering process and governance excellence to all areas of External Quality.
- Ensure the GEO site and business partners are Inspection Ready.
- Support the External Quality Site Head in the development, adoption, and management of the functional strategy for the team.
- Other duties as assigned.
- Bachelors or equivalent degree required. Advanced degree in science, engineering, or MBA highly preferred.
- Bachelor’s degree with 8 years of experience; Master’s degree with 6 years of experience; or PhD with 4 years of experience across multiple competitive, fast paced environments E.g., pharmaceutical R&D, clinical development, commercial operations and/or strategy consulting.
- Experience managing large projects within a complex matrixed organization either as an external consultant or an internal cross-functional lead. PMP preferred.
- Demonstrated ability to present data and metrics to executive leadership teams that will lead to better business outcomes.
- Recognized team player with proven facilitative leadership skills in a cross-functional global team environment. Proven performance in a matrix environment with ability to influence and align stakeholders.
- Excellent interpersonal skills. Ability to interact externally and internally to support business strategy.
- Strong analytical skills. Recognized ability to evaluate complex issues from multiple perspectives to ensure that balanced risk assessments are made.
- Excellent oral and written communication skills.
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.