- 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, and 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 the development, administration, tracking, and maintenance of training programs in accordance with the GxP requirements.
- Leads and manages the quality and training department's resourcing, performance evaluation, productivity, engagement, and development.
- Reports and elevates serious risks and issues to executive attention in a timely manner.
- 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 and Compliance - Rockville, United States - EMMES Corporation
Description
Head of Quality, Compliance, and Training
The Emmes Company, LLC 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
- 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 executives 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 regulatory requirements (GCP) and industry standards. This role can be based anywhere in North America or Europe.
Responsibilities:
Qualifications:
- 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, and 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
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:
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.
