We are looking for high-energy, dedicated leaders who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and collaborating to deliver outstanding work, we have an opportunity for you to lead our global quality and compliance department. This is a remote, home-based opportunity available anywhere within the United States (preference for East Coast).
At Precision for Medicine, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We handle every aspect of clinical trials from initial strategy and design to selecting sites and executing quality clinical trials.
About you:
You understand the importance of assessing, analyzing, and mitigating risk
You love to lead global teams and provide mentorship and direction
You are known to be organized, results-focused, and able to prioritize
You possess strong strategic, analytical, and problem solving skills
You are passionate about improving patient’s lives through successful drug development
What your day to day will look like:
As a member of Precision for Medicineâs senior leadership team, you will be responsible for the Compliance and Quality systems, practices, and personnel across our global businesses, including the laboratories, clinical trial practices and translational informatics. You will:
Develop, implement, and monitor quality and compliance program across global lines of business that is unified and coherent, adjusted to suit the needs and requirements of each line of business
Establish a culture and attitude of ongoing compliance and continuous improvement in Precisionâs quality standards
Ensure compliance with applicable internal and external regulations, standards, policies and procedures
Lead, direct and/or coordinate all auditing activities from clients audits to health authority inspections including preparation, hosting, providing follow-up and closure
Monitor and plan audits of compliance with programs and policies, ensuring a process is in place to ensure issues are addressed timely
Direct and execute the process to develop, revise, and maintain all SOPs
Ensure accurate training for all stakeholders on SOPs and other processes
Lead all aspects of planning for site or vendor audits
Make recommendations to executive management for investments and improvements
Provide SME support for acquisition due diligence assessments
Lead integration of acquisition partners and plan their adoption of Precision policies
Partner with contract and legal personnel to ensure contents of legal documents are consistent with our internal processes, industry standards and ICH/GCP guidelines
Build and lead a global team of professionals
Qualifications:
Minimum Required: 4-year college degree in the life sciences
Other Required:
25+ years of quality systems leadership in pharmaceutical/CRO industry with accountability for industry compliance and quality deliverables and services
Experience building quality/compliance function/teams
Management experience of personnel across geographic regions
Knowledge of global quality systems, reporting and life cycle developed/maintenance
Command of US, EU and International regulatory standards and GXP guidelines for clinical trials
Understanding of ISO, CLIA, GCP standards as applicable
Possesses practical knowledge of IT tools and systems
Experienced at project management including development and maintenance of departmental budgets
Ability to travel up to 25% domestically and internationally including overnight stays
Preferred:
Graduate, postgraduate degree
CRO experience
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
Find one job in US 