The Head of Regulatory Affairs and Quality Assurance will be responsible for overall management of Quality and Regulatory activities in support of Frontiers growth objectives. In addition to their externally facing activities, they will play an important role collaborating cross-functionally with groups across Frontier. The head of RA/QA will be a key leader in enhancing and developing the organizations RA/QA capabilities and qualifications to enable strategic initiatives. They will also be responsible for devising and implementing regulatory strategy and providing leadership oversight for all regulatory submissions, regulatory compliance, regulatory advice, and counseling in all areas of development. They position reports to the CMO.
Role Responsibilities
- Development, implementation, maintenance and overall success of the company’s regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.
- Implementing process improvements required to ensure GxP compliance in early clinical development environment with strategic view to grow Quality function as the products advance to late-stage development and commercialization.
- Building and managing relationships with FDA and global regulatory agencies and standards groups.
- Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
- Developing and maintaining current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions.
- Coordinates internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
- Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective.
- Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
- Serve as the company representative for the FDA and other relevant external stakeholders, including Frontier partnerships.
- Ensure supplier quality objectives are met
- Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines.
- Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality.
- Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements
- Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance.
- Develop and manage department and study-specific budgets.
Key Skills and Experience
- The Head of RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.
- Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions
- Direct experience with FDA Quality System Regulations and regulatory requirements and implementation.
- Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
- A commercial focus in the application of regulatory requirements.
- Outstanding communication skills, both verbal and written, and the ability to interface effectively across key functional areas.
- Strong conceptual, analytical, and problem-solving abilities.
- Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.
- Proven experience in leading change management initiatives through periods of rapid expansion.
- Working knowledge of multiple business functions, including operations, quality, logistics, finance, sales, customer service, engineering, IT, and human resources.
- Role is office based and will travel based on business needs, typically 10-30%, but flexing higher when needed.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Free Food & Snacks
- Wellness Resources
- Stock Option Plan
At Frontier we strive to build a diverse and equitable workplace. The salary range for this role is $225,000 – $300,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.
This compensation and benefits information is based on Frontier’s knowledge as of the date of publication, and may be modified in the future.