- Designs, develops, and implements a forward-facing Clinical Quality Management System, fit for a growing, industry leading CRO.
- Serves as the primary senior leader for all quality and compliance related matters across business units, including customer complaints and whistleblower issues.
- Supports mergers and acquisitions due diligence and decision making from a quality and compliance perspective.
- Attends and reports at Board of Directors Committee meetings as required.
- Oversees the Quality Management System in compliance with regulatory requirements and company strategy and ensures it is appropriately documented and implemented (change controls, deviations, CAPAs, SOPs, validation protocols, product specifications, training documentation, etc.)
- Identifies and rectifies any company QMS gaps versus industry QMS standards.
- Develops and implements a quality governance framework and defines appropriate KPIs to monitor the efficiency of the Quality Management System
- Develops and maintains risk-based methodologies and conducts quality reviews
- Maintains up-to-date knowledge of FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities across the organization
- Supports the management of the electronic document management system and all other electronic systems used as part of the Quality Management System
- Establishes and oversees an appropriate audit program (internal and external)
- Oversees external audits and leads inspection preparation and defense
- Oversees development, administration, tracking, and maintenance of training programs in accordance with the GxP requirements
- Leads and manages the quality and training departments resourcing, performance evaluation, productivity, engagement, and development
- Reports and elevates serious risks and issues to executives attention in a timely manner
- Bachelors or Masters degree in Life Sciences or a related scientific field
- CQA, CCRP, ISO certification (or equivalent) required
- 15+ years of experience working in Biotech/Pharmaceutical industry, 10+years in a GCP Quality and Compliance related role
- Extensive GCP quality experience in the pharmaceutical industry, CRO experience preferred
- Advanced knowledge and understanding of GCP regulatory requirements and implementation (FDA, EU, ICH & country specific regulations and other relevant guidance governing GCP activities)
- Understanding of drug-candidate development
- Knowledge and experience of ISQA
- Leadership skills at an executive level
- Strong written and verbal communication as well as problem-solving skills
- Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a day-to-day basis as well as balance the unexpected needs of the company as they arise
- Demonstrated organizational skills, high attention to detail, and ability to multi-task
- Microsoft Office proficiency
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
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Head of Quality, Compliance, and Training - Rockville, United States - The EMMES Corporation
Description
Overview:
Head of Quality, Compliance, and Training
US Remote
The Emmes Company, LLC (Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our Character Achieves Results culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us You will be joining a collaborative culture that empowers every Emmes employee from entry level through top executive to contribute to our clients success by sharing ideas openly and honestly.
Primary Purpose
Reporting to the Chief Executive Officer, the Head of Quality, Compliance and Training will be the Chief Quality Officer (CQO) and the senior member of the Leadership Team responsible for developing, implementing, and maintaining the Company's Quality Management System in alignment with company strategy and objectives and with the regulatory requirements (GCP) and industry standards. The Head of Quality, Compliance & Training will also oversee all corporate and GCP training as well as actively shape company and functional strategies (including business development, capability expansion, and M&A strategy) through their insight and experiences. This role can be based anywhere in North America or Europe.
Responsibilities:Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
CONNECT WITH US
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - The Emmes Company, LLC
The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
