Senior Director, Device Quality

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response.

Job summary

The Senior Director, Device Quality is located onsite in San Diego, California and is responsible for leading the global quality programs and strategy for the Company in support of medical devices. Reporting to the VP, Quality, the Senior Director has a supporting role in developing the strategy and hands-on tactics for the Device Quality function for the Company on a global basis.

The Senior Director plays critical and supporting role to the VP Device Quality in ensuring total quality excellence across the whole of the global organization, including multiple device CMO organizations, outside laboratories and vendors, internal GMP device support groups, and internal Device manufacturing.

In this role, the Senior Director must have hands-on experience developing and commercializing products in compliance with 21 CFR Part 820 / Part 4, ISO 13485, and EU MDR.

In this organization, the Senior Director leads a significant team of quality professionals across multiple device projects such as supply chain, quality control, quality assurance and document control. The Senior Director leads, permeates, and embodies the quality philosophy of the Company.

Essential job functions and duties

* Assist the VP of Device Quality to drive, direct and control the activities of the Device Quality function within the company on a global basis, including quality oversight of DHF, CMO organizations, vendors, and other related partner companies.

* Develop and lead the Company's Device Quality strategy with an emphasis on Design Control and Risk Management, and support and execute a global Quality strategy. Develop and approve specifications, essential performance requirements (EPRs), essential drug delivery outputs (EDDOs). Provide related summaries and recommendations to the VP QA.

* Key contributor to develop and lead the Company's Device Quality System to ensure compliance and continuous improvement to execute a global Quality strategy. Provide related summaries and recommendations to the VP QA.

* Develop and maintain a comprehensive, personal understanding of the company's worldwide operations, technology, financial performance, and strategies.

* Manage quality events, license/certificate/registration renewals, and changes that impact customer satisfaction and performance to company goals and objectives.

* Drive implementation of programs and processes to maintain a superior and consistent level of quality performance across the device organization.

* Be an expert in execution of device quality systems and operational excellence initiatives that enhance performance, improve quality, reduce cost and generate sustainable quality improvement.

* When needed, serve as the Management Representative in support of ISO certifications and the Quality representative PRRC (Person Responsible for Regulatory Compliance) for EU compliance.

* Support device regulatory filings, master file amendments, responses to questions, etc.

* Lead an effective Device Quality organizational structure that provides mentoring and coaching to staff and promotes a culture of inclusion, recognition, accountability, and high performing team members.

* Plan and manage the Device Quality budget with the VP QA and allocate necessary resources to meet objectives and timelines.

* Serve as a key contributor to develop the manufacturing facility into a commercial device entity, assist with hosting global regulatory inspections with a high degree of success.

* Assist with associated activities such as harmonized INOVIO QA programs (Training, Complaints, etc.) across Clinical, Drug, Device, IT and R&D.

Minimum requirements

* Bachelor's degree in a relevant course of study. Advanced degree (MBA, etc.) and certifications preferred.

* Minimum 10 years of directly related Device experience within the Quality function within a leading corporate environment in the life sciences industry; and 7 years of directly managing a staff of device quality personnel, with an emphasis on career growth, recognition, teambuilding, conflict resolution and organizational structure; and 5 years of outstanding senior leadership experience, including a strong background in maintaining a positive cross-functional team culture across engineering, regulatory, manufacturing, and quality.

* Background within the medical device development, change control, supply chain and manufacturing functions, and a hands-on approach to leading the Quality function with a focus on process improvement.

* Extensive experience working with domestic and international customers, facilities, suppliers and products.

* Able to use judgment when evaluating compliance issues from Phase 1 through Commercial levels of compliance.

* Be an inspiring leader, mentor, coach and motivate Quality and operations staff to excel and produce products of the highest quality.

* Excellence in written and oral communications.

* Possess practical and pragmatic working knowledge of cGMPs for devices, ISO, US and EU regulations. Able to oversee the Quality aspects of Software and Hardware development and control.

Disclaimer

INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO