Director, Clinical Development Quality Assurance and Compliance

Waltham, MA, United States

ABOUT US

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

This is your chance to be part of the company with the first mAb authorized in over a year and the only one currently on the market for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.

Be part of making a difference. Be part of Invivyd.

Position summary:

The primary responsibility of the Director of Clinical Development Quality Assurance and Compliance will be to develop and lead all quality assurance and compliance activities for the clinical development organization at Invivyd. The individual will be responsible for driving Clinical Quality initiatives to completion in conjunction with Invivyd's Regulatory and Clinical departments and external vendors. This position will also be responsible for coordinating, controlling, and continuously improving the internal quality assurance processes, primarily related to clinical development and related activities and systems. The Director will coordinate audits to support GCP and other regulated activities and lead strategy and activities in support of health authority inspections. The individual will ensure compliance of clinical trials and development activities to global regulatory standards including FDA, EMA, and other international regulatory agencies. They will also be responsible for clinical inspection readiness activities for Invivyd's development programs.

* Build the Clinical Development Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and other compliance-related activities such as GDPR compliance

* Develop a risk-based audit program to conduct effective audits of internal processes, investigator sites, and vendors that support development activities

* Create, implement and maintain efficient, phase-appropriate and compliant GCP systems

* Partner with stakeholders to develop GCP-focused SOPs, policies and procedures consistent with corporate objectives

* Partner with other stakeholders within Invivyd (i.e. CMC) to build cross-functional and corporate policies and procedures and integration of systems/activities, when appropriate

* Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management

* Provide QA Support for Clinical Vendor/CRO oversight:

* Represent Invivyd QA on Sponsor/CRO/Site project calls and provide updates to Management

* Provide QA support for critical quality issues, protocol deviations and investigations

* Assist in the development and implementation of GCP training programs and conduct training sessions as required

* Establish quality procedures and tools in support of audit and compliance activities

* Collaborate with key stakeholders in development and implementation of internal and external GCP audit plans;

* Proactively identify potential quality issues/discrepancies and work with Management to effectively resolve in a compliant and timely manner;

* Research changes and updates to ICH, GCP regulations and assess impact on Invivyd systems and practices;

* Assist in the preparation and coordination of internal and external stakeholder meetings

* Participate on cross-functional team meetings as QA Subject Matter Expert

* Lead activities in support of health authority inspections

* Review regulatoryF documents and check for consistency and compliance with relevant regulations, standards and best practices

Competencies:

* Excellent written and oral communication skills, with the ability to communicate complex information in a virtual environment;

* Ability to work in a team and independently

* Strong organizational skills with the ability to effectively multi-task and prioritize;

* Ability to flexibly adapt to changing business needs and meet timelines;

* Ability to analyze & interpret analytical data;

* Ability to determine impact of issues on subjects, study conduct, clinical program development and company needs based on stage of development and risk profile

* Strong attention to detail and good problem-solving skills;

* Resourceful, self-starter and team player with a strong results orientation.

Requirements

* A Bachelor's degree in a scientific discipline or biotechnology field;

* A minimum of 8 years relevant GCP experience in pharma/biotech company, working within quality systems and regulated GCP/ICH environments;

* Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory agency inspections;

* Experience managing internal and external audits,

* Strong understanding of GCPs, FDA, EU and ICH regulatory standards/guidance documents;

* Extensive knowledge of risk-based quality systems approaches, with a focus on ICH E-6 R2 GCP principles;

* Ideally will also have experience in facilitating/participating in remote audits and quality activities; able to travel to Clinical sites/vendors as required; Travel Requirement expected to be 25%.

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.

We do not accept unsolicited resumes from agencies.

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