Compliance Manager: Risk Management (REMOTE)
Posting ID: JP-002191071
• Develop and implement a sustainable Global RM program, inclusive of risk management strategy, policies and procedures, tools, training, metrics, and a governance model to support the global program across the network in collaboration with cross functional partners • Lead cross-site, cross-functional socialization effort for the RM program to raise awareness and promote branding • Develop and implement a sustainable process for collecting, evaluating and adopting regulations and guidance based on data, scientific knowledge and industry intelligence • Effectively communicate risks, insights and implications for Gilead to senior leadership with presentations, periodic updates and written reports • Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training • Develop and maintain electronic systems (e.g. Veeva) to provide standardized RM processes to cross-functional partners. • Leverage data analytics to improve existing RM tools and capabilities • Facilitate risk assessment activities as needed • Coach and mentor junior staff supporting RM program deliverables • Other responsibilities as required or assigned by Manager to meet business needs
quaity assurance, Project management, Risk management, Quality assurance, Gmp, Fda, Capa, Batch record, Qa, Inspection, Sop, batch record review, BRR, aspetic
Top Skills Details:
quaity assurance,Project management,Risk management
Additional Skills & Qualifications:
• Strong working knowledge of cGMP (FDA, EU and ICH Q9) requirements and the ability to assess compliance risks. • Working knowledge and hands-on experience with risk management tools (e.g. risk registers, FMEA, risk ranking and filtering, HACCP, etc.). • Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs • Strong oral and written communication skills • Demonstrates thorough knowledge of compliance requirements and understanding of current global and regional trends in risk management and compliance • Capable of taking a leadership role in updating and preparing the company for changes in regulations and culture. • Ability to analyze, interpret and distill large amounts of information into key messages • Use critical thinking skills to operate with incomplete information • Accountable to own actions and keep commitments • Strives to continuously build knowledge and skills; and shares expertise with others • Capable of leading a small team in development of systems and procedures and implementation. • 8+ years of relevant experience in the pharmaceutical industry and a BS or BA or 8+ years of relevant experience and a MS.
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Rehat Singh
Phone: (973) 829-4395