Direct the activities for the worldwide Regulatory Affairs and Quality Assurance/Compliance Groups within the highly regulated bio-pharmaceutical industry
Direct the activities for the worldwide Regulatory Affairs and Quality Assurance/Complianace Groups within the highly regulated bio-pharmaceutical industry framework to ensure that the Company's products comply with international quality standards and meet regulatory requirements leading to product approvals by the regulatory authorities as rapidly as possible.
* Oversee Regulatory Affairs and Quality Assurance worldwide with emphasis on US, Europe and Canada. Assume overall responsibility and liability for performance against results. Motivate employees to fulfill their obligations and inspire them to want to achieve results. Has the managerial courage to establish consequences when necessary.
* Interact with Cerus management and external agencies to define and develop broad regulatory strategies consistent with business objectives and regulatory requirements.
* Maintain knowledge and understanding of quality standards in the worldwide markets to assure compliance.
* Assume an independent role for making quality decisions on lot release and market actions such as recalls, field corrections and performance of suppliers and contract manufacturing partners.
* Maintain a high profile interface with associations and external groups to increase Cerus' influence and ability to take advantage of a changing regulatory environment.
* Represent Cerus externally in discussions with regulatory authorities worldwide with emphasis on the U.S., Europe and Canada..
* Perform the duties of Cerus' Quality Management Representative.
* Provide insight into the potential quality and regulatory risks and benefits of Cerus' business plans, including directing alternative action plans based on risk/benefit analyses.
* Develop and implement regulatory strategies aimed at gaining the earliest possible regulatory approvals as well as the tactical execution of all regulatory submissions and filings.
* Develop regulatory strategies, systems and processes to ensure that Cerus' development, registration and commercialization plans meet all federal, foreign, and company requirements to enable the effective advancement of products from design concept through marketing, and post market surveillance.
* Interact with executive team on a peer basis as part of the Senior Management team for setting strategies and execution on Corporate goals.
* Oversee and participate in the writing, review, editing and compilation of regulatory submissions and quality documentation.
* Ensure Cerus compliance to federal and international regulations and standards related to drug and device development and commercialization.
* Develop and implement quality management system processes to ensure the system effectively meets the objectives of the Corporate Quality Policy.
* Assure completion of departmental tasks and projects and actively gather staff feedback and perspective. Establish policies and procedures based on accepted principles, and ensure adherence to these policies and procedures.
* Manage and participate in human resources/organizational development activities including; recruitment of key regulatory and quality personnel, performance management, employee development and training), mentoring and motivating teams and department leadership to maintain stability in the departments.
* Ensure budgets and schedules are met.
* Perform other related duties as required.
* Master's degree or Ph.D. (preferred) in related field or equivalent related experience.
* Minimum 18 years regulatory and clinical experience; includes quality management experience or equivalent combination of education and relevant regulatory experience; includes 10 years management background.
* Thorough understanding of U.S. and International regulatory requirements and standards for development, clinical testing, manufacture, marketing, and distribution of either medical devices or biologics, preferably experience with both.
* Experience in all phases of product commercialization, including product development, product approvals and post-approval.
* Demonstrated ability to interact successfully with regulatory agencies, including in a strategic role.
* Ability to integrate regulatory expertise with Cerus business objectives; strong sense of Company with ability to translate corporate goals into project plan.
* Subscribes to and models Cerus' management expectations.
* Recognized as an effective leader; strong leadership, management and mentoring skills; team oriented.
* Ability to effectively communicate, coordinate and interact with upper management, managers and personnel within other departments (encompasses verbal, written, interpersonal, listening); interpersonal skills and ability to communicate across multiple disciplines successfully and accurately (internally and externally, e.g., FDA and international regulatory authorities).
* Strong negotiation skills.
* Time Management (timelines, schedules, task prioritization).
* Attention to detail and accuracy.
* Flexible; ability to adapt to changing priorities.
* Able to fully understand scientific, medical and manufacturing disciplines.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.