Vice President of Quality & Regulatory Affairs

Full-timeDescription

The VP, Quality & Regulatory Affairs is responsible for the development and execution of the Company’s quality and regulatory program. This includes support of all drug development and manufacturing activities, directing cGxP quality related activities across the organization to support regulatory submissions, company goals and ultimately commercial launch of products. This position provides quality and regulatory direction and oversight for the Company’s portfolio of Active Pharmaceutical Ingredients (APIs) and drug products, with respect to regulatory strategies and submissions, ensuring that current and anticipated FDA requirements and standards are met.This position requires expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and Good Laboratory Practices (GLP) and relevant regulations.It is intended that Phlow operate within a network of manufacturing, development, and quality control/assurance partners and this role will have overall accountability for Phlow’s interests in the quality assurance and compliance aspects of these partnerships.

The VP, Quality is the final decision maker on all aspects of product quality, GXP Compliance, and product disposition.

· Ensure the Quality System meets standards expected by regulatory authorities for development and commercial activities for all impacted and intended markets· Ensure quality metrics comply with best industry standards and practices. · Maintain an effective Quality governance and continually improve governance to meet and exceed business and compliance needs. · Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance. · Ensure products manufactured meet company quality standards, government regulations and expectations. · Counsel, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance. · Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management. · Continually establish and improve quality systems, initiatives, priorities and timelines. · Establish strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements. · Establish strong working relationships with internal partners ensuring alignment of quality systems and procedures with company goals and objectives. · Identify areas for potential optimization of workflows and data streams improving productivity and compliance with all operational partners· Serve as an escalation point for corporate quality issues. · Responsible for supplier/vendor quality oversight. · Serve as primary contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency. · Define regulatory submission strategy and documentation requirements for routine and complex submissions such as those employing novel manufacturing technologies.

Identify potential risks to approval (deficiencies) and mitigation strategies, drive stakeholder alignment and endorsement.· Represent the company on regulatory issues in interactions with FDA and other governmental agencies and take the lead in organization and preparation of official meetings with FDA. Participate in industry groups dealing with strategic issues relevant to the Company.· Provide leadership to staff (including external CMOs) in the planning and operational preparation of submissions (Type II Drug Master Files, Abbreviated New Drug Applications) throughout product lifecycle, including content and electronic submission requirements. · Build and develop the regulatory staff commensurate with the growth of the Company’s business; allocate resources to ensure projects and submissions have appropriate regulatory expertise. Develop an agile staff that can adjust quickly to changing priorities and business needs. Justify, secure, and supervise external consultants as appropriate.· Build partnerships with key stakeholders in other functions within the Company, with partners and external contract manufacturing organizations, to ensure that strategic business goals are met through sharing of knowledge and expertise.· Manage regulatory maintenance activities for the Company’s portfolio of applications, in compliance with the regulatory obligations of the DMF Holder and ANDA Holder, including change control management and appropriate submissions to DMFs or ANDAs; annual reports, fees, as required; notification to FDA of market supply interruptions in accordance with FDA requirements and timelines.· Collaborate with and provide regulatory support to the Quality function in handling of quality defects; participate in decision-making for Field Alert Reports (FARs). Provide regulatory support for CGMP inspections and contribute to responses to inspectional observations (Form FDA 483), as applicable.· Maintain deep and broad knowledge of current and evolving U.S. regulatory requirements that are relevant to the Company, with focus on CMC regulatory knowledge, including marketing applications and post-marketing regulatory compliance; assess impact of new regulatory requirements, and take leadership to educate organization. · Conduct all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines. · Create a lean and efficient business model while at the same time building a quality culture with partners and internal colleagues · Other duties as assignedTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· 20+ years of relevant combined experience within the Biotech and Pharmaceutical industries focused on  GxP, QA management or QA leadership positions, demonstrating increasing responsibilities · Quality or Regulatory. A minimum of twenty (20) years in the pharmaceutical industry in Drug Regulatory Affairs, or at FDA, including both development and post-marketing regulatory experience, plus supervisory experience. · Experience and record of success with regulatory strategies and regulatory submissions of NDAs, ANDAs (preferably including hands-on experience) resulting in approvals, and experience in preparing and leading meetings with FDA. · Demonstrated record of applying 6-sigma, OPEX and LEAN philosophies in designing/implementing quality systems and problem resolution · Deep understanding of GxP Regulations and Regulatory requirements required for Pharmaceutical productions, Active Pharmaceutical Ingredients. · Deep understanding of quality systems implementation including document management, CAPA, deviation, Change Control and training · Must be proficient in MS SharePoint, MS Office 360 (MS Word, MS Excel, MS PowerPoint), Adobe Acrobat Pro.· Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred

· Bachelor's degree or Master's degree in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered. 

· Ability to work in a cross-functional team environment with changing timelines and priorities required.· Demonstrated organizational skills, strong verbal and written communication skills, attention to detail.· Exhibits the highest level of reasoned judgment, discretion, and integrity. Integrity is our defining characteristic at Phlow· Collaborates with others to achieve shared objectives. At Phlow, we are focused on working together, accepting feedback, and making it about results· Ability to thrive in a fast-moving, continuous learning environment; iterating and learning as a team· Active listener with a curious and open mind· Steadfastly pursues excellence in execution· Servant leaderRequirements

•Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.•Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.•Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.•Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.•Occasionally lift and/or move up to 10 pounds.•Travel anticipated to be approximately 5% with occasional increase in travel demands based on business needs.