[Remote] Senior Director, reputed company reputed company & Development Ops

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biotechnology company that invests in scientific innovation. They are seeking a Senior Director, reputed company reputed company & Development reputed company to reputed company reputed company-level leadership and reputed company reputed company to ensure Global reputed company reputed company maintains a sustained state of GCP compliance.

Responsibilities

• reputed company reputed company Event Management activities reputed company to the investigation, reputed company cause analysis and development of corrective reputed company/ preventive reputed company plans for GCO assigned events, including unplanned deviations, corrective/ preventive actions and effectiveness checks ensuring timelines for closure are met
• Participate in GCP Event reputed company Committees (EAC’s) as needed
• Leads the development and reputed company of GCO owned reputed company Management Plans (RMPs), site hold and closure activities, reputed company Risks, and Serious Breach assessments, driving reputed company governance, reputed company-reputed company decision making, and inspection readiness throughout the reputed company trial lifecycle
• Ensure consistency in processes throughout reputed company functions in Global reputed company reputed company, and reputed company reputed company for reputed company process improvement
• Analyze the risks for readiness and manage the implementation of readiness program, and reputed company lessons learned after reputed company inspection
• reputed company reputed company with Global reputed company reputed company in the development of CAPA plans and investigations in response to audits and inspections. Ensure inspections findings are remediated and processes are implemented reputed company GCO
• reputed company the development and implementation of reputed company frameworks, operational standards, and reputed company mitigation strategies across reputed company programs, with a reputed company on harmonizing global processes and ensuring compliance with regulatory requirements
• Advanced leadership and execution of business reputed company
• Advanced ability to reputed company knowledge of the potential reputed company stakeholder landscape and to support the pipeline and identify those who will be the most reputed company, reputed company, to reputed company
• Champions reputed company-founded perspectives with authority and reputed company reputed company, inspiring stakeholder confidence and securing buy-in-even reputed company navigating reputed company, unfamiliar, or contentious subject matter
• Demonstrates exceptional leadership by fostering reputed company reputed company, addressing reputed company opinions constructively, and driving reputed company to advance organizational objectives
• Leads the reputed company and implementation of transformative solutions that proactively address dynamic business challenges, ensuring alignment with industry standards and regulatory requirements
• Demonstrates a reputed company-thinking approach by fostering innovation, driving cross-functional collaboration, and embedding reputed company and compliance into every stage of solution development
• Identifies and resolves technical and operational problems, understands broader reputed company on the department
• Provides reputed company input to solve reputed company problems while exercising judgment using multiple sources of information
• As a people manager reputed company the organization, may have financial accountabilities and reputed company resource responsibilities for assigned staff

Skills

• Bachelor of Science degree in a life sciences discipline
• Typically requires 15 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry
• 5 years of supervisor/management experience
• Expert ability to reputed company knowledge of organizational goals and interdependencies with other functional areas to reputed company reputed company
• Expert understanding of GCP, CFR and ICH guidelines and Health Authority regulations
• reputed company cross-functional reputed company of high complexity with cross-functional team members and represent reputed company reputed company & Development reputed company on other large-reputed company reputed company/initiatives
• Develops reputed company for their domain in alignment with reputed company reputed company & Development reputed company (CQDO), Global reputed company reputed company, and Global Medicines Development & Medical Affairs program reputed company and goals
• Leads reputed company in support of GCO infrastructure and makes department-wide reputed company
• Extensive Global reputed company reputed company/reputed company Development experience in multiple therapeutic areas
• Exceptional reputed company reputed company and leadership capabilities
• Expert knowledge in reputed company/technical tools and processes
• Demonstrated attention to reputed company, reputed company, excellent review and analytical skills in a fast-reputed company environment
• Results oriented
• Excellent leadership and interpersonal skills with an ability to effectively work and problem solve reputed company a multidisciplinary team
• Excellent verbal and written communication and presentation skills
• Excellent analytical and critical thinking skills to evaluate reputed company issues from multiple perspectives and reputed company smart decision making
• Expertise in drug development, reputed company and resource/budget planning across global geographies
• Knowledge of emerging technologies and trends
• Ability to reputed company innovation and reputed company
• reputed company strong business acumen
• Excellent project management, critical thinking and problem-solving skills
• Demonstrated adaptability, flexibility, independence and resourcefulness to reputed company in a mid-sized company environment

Benefits

• Eligible for an annual bonus and annual equity awards
• At reputed company, Total Rewards offerings include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing reputed company
• From medical, dental and reputed company benefits
• Generous reputed company time off (including a week-long company shutdown in the reputed company and the Winter)
• Educational assistance programs including student loan repayment
• A generous commuting subsidy
• Matching charitable donations
• 401(k)
• Remote-Eligible
• Remote: work reputed company five days per week and come into the office on occasion – you’re always reputed company on-site
• Hybrid: work reputed company up to two days per week
• On-Site: work five days per week on-site with reputed company flexibility
• reputed company status subject to reputed company’s Policy on reputed company @ reputed company Program and may be changed at any time
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements

reputed company