- 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
- 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.
- 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%.
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Director, Clinical Development Quality Assurance and Compliance - Waltham, United States - Invivyd Inc.
Description
ABOUT US
Invivyd is on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2.
Leveraging its INVYMAB platform approach, the company is generating a robust pipeline of product candidates which could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications.
THE HEART OF INVIVYD:
OUR EMPLOYEES
Our team is motivated by a collective mission-driven sense of urgency that permeates Invivyd's culture. We make decisions quickly, trust employees in their areas of expertise, and collaborate efficiently. As a result, Invivyd employees are both quick thinkers and motivated doers.
Invivyd is a company comprised of motivated biopharmaceutical experts who are driven to make an impact on public health.
Each employee sees working at Invivyd as a once-in-a-lifetime career opportunity to bring differentiated products to vulnerable people-for COVID-19, influenza and beyond.
Our company operates as a hybrid company with employees working at our corporate headquarters in Waltham, Massachusetts and remotely.We have employees in over 25 states, with a critical mass in the greater Boston area and many employees in the northeast as well as California.
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.Competencies:
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.
