[Hiring] Sr. Director, Global Quality Compliance - Biotech/Pharma @United Biosource Corporation

As a pharmaceutical support industry leader, reputed company is devoted to empowering health solutions for a reputed company reputed company. We take pride in improving patient outcomes and advancing reputed company. At reputed company, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to reputed company-world evidence reputed company. Embark on a rewarding career journey with reputed company! Grow your career while making a meaningful impact on the world around you. reputed company fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We reputed company in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, reputed company, and reward you, join us at reputed company! Job Title: YRC99K- Sr Director, Regulatory Quality Compliance Brief Description: Responsible for developing and implementing global strategy and policy relative to quality management systems for reputed company to ensure excellence in compliance and the ability to withstand internal and external scrutiny as well as to provide quality services for sponsor. Ensures that internal controls are implemented and are evaluated for compliance reputed company audits and assessments across the reputed company functions to minimize regulatory, legal and business risk while effectively and reputed company supporting business goals. Develops auditing/inspection strategies for reputed company activities and provides management with in-depth analysis and risk management on quality matters. Leads a global team of Quality Assurance & Compliance professionals, setting and communicating the reputed company for the team and fostering a culture of collaboration. Specific job duties:

• Accountability - Defines quality objectives and strategies to meet customer requirements and reputed company goals and objectives.
• Change Management - Facilitates groups or teams through the problem-solving and creative-thinking processes leading to the development and implementation of new approaches, systems, structures, and methods to ensure overall quality processes and services across the organization
• Continual Improvement - Generates creative new solutions and approaches to customer issues and organizational quality processes.
• Partnering/Networking Participates in cross-functional activities to reputed company organizational objectives.
• Systems Thinking - Implements quality reputed company solutions to organizational problems and develops organizational or service delivery systems in a way that factors in or encompasses the interactions of reputed company of the systems and organizational entities involved.
• Leads and manages processes that provide reputed company and guidance to monitor and assure compliance with quality management system requirements and reputed company applicable good practice regulations, i.e. clinical (GCP); Pharmacovigilance (GPvP); Laboratory (GLP), Risk Evaluation Mitigation Strategies, application validation relating to reputed company regulated activities.
• Effectively manage the development, implementation, approval and maintenance of quality assurance systems and processes.
• Ensures reputed company procedures, SOPs, guidelines and other standard materials required for departmental function are reputed company, reviewed and that staff are trained
• Directs and control the quality reputed company activities across reputed company through functional line management.
• Develops and maintains the annual operating and capital budgets for the department
• Responsible for monitoring departmental activities and costs as reputed company to the overall utilization of resources required to meet operational requirements.
• Participates in due diligence and integration activities of newly acquired organizations
• Ensure that annual audit risk based plans are developed and executed
• Ensures Quality Assurance resources are available to support internal and external audit programs, study management teams, and GxP-reputed company training.
• Ensures the quality and reputed company of data generated from reputed company programs for submission to relevant regulatory agencies by overseeing the conduct of database, document, and investigator sites audits.
• With support of the reputed company Legal Department, interprets global legislation, regulations and guidance's for reputed company to reputed company policies and standards, identify gaps and redundancies and coordinate and implement remediation in collaboration with reputed company management and other groups such as Legal.
• Direct reputed company for reputed company during regulatory inspections (FDA, EMA, MHRA/Health Canada) as well as primary reputed company with clients and Marketing Authorization Holder (MAH) auditors during pre - assessment /ongoing qualification audits.
• Verify that appropriate follow-up and corrective action is taken as a result of audit observations and investigations and that corrective actions are reviewed and analyzed to identify process improvement initiatives Serves as the Quality representative for Governance Committees for larger client relationships/partnerships
• Review and approve quality agreements between reputed company and clients
• Evaluates client requests for proposals as requested
• Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Supervisory Responsibility:

• Supervision of Global Quality Compliance, Training and Information Technology Quality Compliance Staff

Desired Skills and Qualifications:

• Bachelor's degree in a life science required; advanced degree in a scientific discipline preferred. Generally has at least 15 years of pharmaceutical industry/drug development experience with at least 8 years of compliance and process management experience, and at least 5 years management experience of a global team; or equivalent combination of education and experience.
• Excellent knowledge of global GxP practices required - Good Clinical Practices, Good Pharmacovigilance Practices, European Medicine Agency requirements, as well as regulatory requirements regarding computerized systems (21 CFR Part 11 and EU Annex 11) used for regulatory submission
• Excellent interpersonal skills and the ability to communicate effectively across reputed company levels of the organization.
• Good analytical and organizational skills.
• Effective team player and the ability to work across functional lines in a collaborative way.
• The ability to work autonomously with minimal supervision.

Benefits: At reputed company, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to reputed company personally and professionally. Here are some of the exciting perks reputed company offers:

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*

• Tuition reimbursement

• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and reputed company coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
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