The Role: Director, Quality Assurance/Regulatory Affairs
Location: Washington DC Metro
Our client is a premier global biological materials resource and standards organization whose mission focuses on the acquisition, authentication, production, preservation, development, and distribution of standard reference microorganisms, cell lines, and other materials.
The company’s headquarters and bioproduction facilities are located in Manassas, Virginia, they have a second facility in Gaithersburg Maryland both locations are in close proximity to the Nation’s Capital and the U.S. National Institutes of Health. The repository portion of the facility occupies 18,000 sq. ft. and contains 200 freezers for the storage of biomaterials, including vapor-phase liquid nitrogen freezers, mechanical freezers, and cold rooms. The repository space is complemented by 35,000 sq. ft. of laboratory space
The company continues on a strong trajectory of growth, with significant growth and expansion. As a part of the company's growth, they are creating a new role for the Director of Regulatory Affairs & Quality Assurance to add to the leadership team.
In this newly created role, reporting to the Vice President, the successful candidate will be responsible for all aspects of the Quality Assurance and Regulatory Affairs function. The Director of Regulatory Affairs & Quality Assurance (RA/QA) will proactively develop, lead and drive the execution of the company's global regulatory and quality assurance strategy. The position will be responsible for regulatory affairs, quality assurance, and compliance activities. The Director QA/RA will establish and implement policies, procedures, specifications and forms for the Quality Management System (QMS) and direct RA/QA staff.
This role must work and think independently; duties of this position are to be completed under minimal to no guidance. Decision-making will be a key component of this position, and decisions have a significant impact on the overall success of the Organization. Discretion in handling assigned responsibilities, including the ability to resolve problems and exercise good judgment while maintaining confidentiality is expected from all company employees.
Duties and Responsibilities:
Define and execute the RA/QA activities to support business unit and corporate strategy; and Responsible for keeping the Executive Leadership Team informed of regulatory status and significant regulatory issues; Manages the function; and Manages annual target budget and capital plan.
Provides counsel, training, and interpretation of the FDA’s and other regulatory authorities’ feedback, policies, and guidelines
Establish, manage and maintain compliance with FDA QSR, including establishment registration, Quality Assurance including, but not limited to, Product Release, CAPA, NCMR, Complaints, Supplier Qualification, Document Control, Training, Internal/External Audits; Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies
Establish, manage and maintain compliance with other global regulatory standards, including but not limited to CE Marks, ISO13485 and 17025.
Develop and maintain external relationships with key opinion leaders, and regulatory officials
Act as the point of contact for all regulatory communication in the company
Responsible for defining the Company’s quality goals each year
Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GLP quality systems and management
Collaborates cross-functionally with internal departments on strategy and implementation of quality principles and regulation requirements
Minimum Qualifications and Requirements:
A Bachelor’s of Science Degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) with fifteen (15) + years’ experience in Quality Assurance and Regulatory Affairs within the biotechnology industry.
At least five (5) years’ experience in management of Regulatory Affairs/Quality Assurance at a biorepository, medical device or pharmaceutical company.
Comprehensive knowledge and understanding of worldwide regulatory standards.
Extensive experience with development, implementation and maintenance of successful regulatory standards compliance programs.
Strong leadership and organizational development skills.
Strong commitment to excellence and a passion for cultivating strong client relationships and championing business growth.
Self-starter, motivated and takes initiative; strong interpersonal and problem-solving skills; able to work collaboratively with all levels of staff to resolve problems and external partners to maximize performance, creativity, problem solving and results.
Seek, learn, and apply new skills/knowledge to perform job responsibilities.
Attentive to detail with a high level of accuracy; exercise sound judgment.
Resourceful, diplomatic and professional; deliver outstanding customer service while managing relationships; a can-do attitude and work style that supports teamwork, collaboration and positive relationships.
Adaptable; be able to shift priorities and focus as departmental and/or business demands change including, but not limited to early/late hours and/or weekend hours.
Strong analytical skills and organized; completes tasks ahead of schedule.
Excellent written and verbal communication skills, including excellent listening skills and presentation skills to communicate clearly, concisely and effectively.
Position-relevant computer experience including Microsoft Office.
Follow all company safety practices, Standard Operating Procedures (SOP’s) and policies.
Internal Number: 11748727
About Nimbus Search Partners
Nimbus Search Partners is an executive search firm with a specialization in the healthcare industry. We are a Woman Owned Minority Business with a focus on the recruitment of mid-tier executives ranging from Senior Manager to Vice President Positions for innovative companies that are leading today’s evolution in the world of business. Our team works together from an assignment’s start through its successful completion to find the candidates who are the right fit for our clients – both strategically and culturally. We strive to exceed clients’ expectations through our relentless execution, market intelligence, and a disciplined approach to search management, client communications and candidate care.
Our principals bring over 20+ years of Talent Acquisition experience with a successful track record in both leading and managing the Corporate Talent Acquisition function as well as with Retained Executive Search firms. We have broad Industry experience with a deep exposure to Life sciences, Biotechnology, Professional Services,Technology and Not for Profit healthcare segments. •
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