Vice President of Quality and Regulatory Affairs

JOB SUMMARY:

Provide expertise for the development, registration, and lifecycle management of our Immuno-Oncology therapies and devices. Responsible for the establishment of successful, expedient, and innovative regulatory strategies for the development and approval of the Company’s products. Engage with Regulatory Agencies in the US and globally to establish effective working relationships and a proficient understanding of policies and the regulatory landscape.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES:

To perform this job effectively, the successful candidate is expected to demonstrate ownership and take accountability for tasks including but not limited to the following:

  • Collaborate with Executive Leadership and Senior Management as well as cross-functional project teams to develop and lead regulatory strategies for TAVO™ intratumoral electroporation therapies for melanoma, breast cancer, and other oncology indications
  • Plan and oversee activities in support of INDs/CTAs, NDAs, MAAs, and other regulatory submissions in the US and globally
  • Act as point-of-contact for the Company’s regulatory communication by liaising directly with FDA and other Regulatory Agencies, including the preparation and leading of meetings with the agencies
  • Implement a global regulatory strategy considering GCP, GMP, etc. (GxP) compliance policies, regulatory filings, supply chain operations, external partnerships, etc.
  • Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective
  • Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the Company’s Development pipeline
  • Collaborate with senior management, all functional groups, and colleagues at all levels of the Company to drive a culture of Quality by conceiving, collaborating, and supporting the implementation of relevant specific actions, processes, and behaviors
  • Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA and global regulations/directives/requirements and ICH guidelines
  • Implement CMC strategies in the quality function via objectives and plans to ensure oversight, timely resolution of issues, and early intervention to assure compliance
  • Identify, resolve or escalate all product, process, or other Quality-related issues that pose any compliance risk
  • Work with and contribute to managing external regulatory- and QA-related CROs and vendors to drive excellence and meet phase-appropriate regulations and timelines.
  • Manage, and provide mentorship and guidance to regulatory affairs and quality assurance departments to ensure staff can operate effectively, e.g., development of technical, GMP, and leadership skills of direct reports, including performance reviews
  • Develop processes and infrastructure that support program needs, including but not limited to SOP development and training
  • Contribute effectively to the development of company business strategy and plan
  • Ensures adherence to company policies, including Privacy/HIPAA, as well as other legal and regulatory directives
  • Oversee and guide personnel actions including, but not limited to, hiring, performance appraisals, merit recommendations, and promotions of RA & QA Department staff
  • Direct long and short-term planning for the department including headcount, budgeting, training, and systems requirements
  • Other responsibilities as assigned

EDUCATION/EXPERIENCE/SKILLS:

  • MS degree in a scientific or engineering discipline required; PharmD, MD, or Ph.D. preferred
  • A minimum of 10 years in life science and biopharma quality roles, including experience across multiple & diverse facilities, working through organizational change, and supervision of highly technical personnel
  • Proven track record of successful NDA filings and prior drug approvals
  • Strong Regulatory Affairs experience with Immunology, Oncology, and/or Inflammatory Disease therapeutic areas
  • Significant experience leading face-to-face and other formal interactions with FDA and other health authorities. Experience with the Oncology division of the FDA is required
  • Solid experience with CMC, clinical, and nonclinical development and regulatory submissions in US; ex-US or global regulatory experience highly desired
  • Background in pharmaceutical manufacturing, including work with contract manufacturing organizations and knowledge of cGMP requirements (e.g., ICH Q7; 21 CFR 210, 211; 21 CFR 600, 610; and corresponding EU requirements, etc.)
  • Experience with cGMP facility registrations and ISO 9001 certifications
  • Solid understanding of QMS within the life sciences industry (eQMS, LIMS, ERP), including quality system design and implementation experience, including, Quality Metrics & KPIs

MUST POSSESS:

  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
  • Experience interacting with FDA is required, and experience with other global Regulatory Agencies is preferred
  • Ability to understand and communicate regulatory requirements for immune-oncology or oncology and countries and associated submission pathways
  • Familiarity with regulatory documents, general contents, organization, and the methods of filing and tracking
  • Familiarity with principles of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and ISO standards
  • In-depth knowledge of clinical research; knowledge of 21CFR11 and EDC systems.
  • Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports
  • Experience coordinating QA activities with the support of a medical device contract manufacturer
  • Process, QMS, or supplier auditing experience desired
  • Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired
  • Knowledge of FDA QSRs, IEC 60529, IEC 60601-1 suite, IEC 62304, IEC 62366-1, RoHS, REACH, WEEE, ISO 13485, ISO 14971 standards and GMP, GLP requirements
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills – resourceful and hands-on
  • Stature to be credible with the management team, characterized by flexibility and emotional maturity
  • A results/solutions orientation supported by strong project and planning management skills, with a high emphasis on quality
  • Self-starter, driven to deliver quality results on time and in a highly ethical and professional manner
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
  • Ability to be detail-oriented with a background adequate to deal with issues related to technical regulations and SOPs, including reading and synthesizing technical material and preparing clear and concise written documents
  • Computer literate and familiar with all relevant software programs at a level allowing utilization of event tracking programs, data loading, and information processing related to regulatory affairs and quality assurance

JOB SCOPE:

As a member of the senior leadership team, the employee will participate in determining and implementing strategies, incorporating innovation, and providing direction for the corporation. With exceptional leadership skills, effectively mentor, motivate, and empower those engaged in functional areas of responsibility. Interacts with Board of Directors and executive-level management requiring strength in analysis, critical decision making, expert negotiation, and bottom-line accountability for the organization.

ADA REQUIREMENTS:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment.  In an office setting, occasionally use hands to finger, and handle objects, tools, or controls.  The employee must occasionally lift and/or move up to 20 pounds.

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To apply, email your resume and cover letter to careers@oncosec.com.  In the subject line of your email, please enter the exact name of the position for which you’re applying.

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