Corporate Compliance Manager is to collaborate with users throughout the company driving Corporate Compliance related matters. This role supports compliance needs, recommending enhanced efficiencies, and administering a compliance program.
Assist key stakeholders with corporate compliance questions
Coordinate and review components of the compliance program
Perform risk assessment and monitoring activities
Uphold transparency and a culture of integrity
Create and implementation ...
Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Establish the Center for Information Security with the above scope of Enterprise Information Security capabilities. Build the Center of Information Security function that has security policies and a standards model which is centralized and leverages a federated posture across other functions and geographies.
2. Develop the enterprise security architecture to ensure that ...
Seeking 5+ years experience in Antigens, Monoclonal Antibodies or related biopharmaceutical products; solid knowledge of ISO 13485 standards, GMP regulations 21 CFR Parts 210, 211 and 820; track record implementating and managing quality systems within a development and contract manufacturing organization; and skills in risk management, tolerance studies, product reliability and safety assessments
Design FMEA, DOE, gauge R&R, SPC, GMP, QSR, design verification, process validation, regulatory audits ...
Primary Function / Primary Goals / Objectives:
Leads and directs all marketing activities for the assigned product line(s) or business. Responsible for the development, management, and execution of strategies and tactical programs to effectively achieve commercialization, profit margin and business plan objectives. Directs and supervises a staff including two or more Marketing Professionals. Additional responsibilities include business strategic planning, concept evaluation forecasting, financial ...
Direct quality assurance activities and quality oversight of cGMP and GMP functions for pharma biologics manufacturing operation with division of global company.
*** Develop and implement strategy, policy and group objectives.
*** Interact with regulators, internal staff and industry experts.
*** Interpret regulations.
*** Manage budget, schedules, staff and other resources.
*** Improve employee productivity -- coach, mentor and develop professional staff.
*** Analyze, assess, manage, ...
The Quality Compliance Coordinator, (Investigator Initiated Trials (IITs), is responsible for supporting Almac Business Development, Operations and Quality personnel at all global sites in the review, development, and execution of work involving IITs in order to ensure that Almac competencies, current regulatory requirements, and industry best practices are met. In addition, the Coordinator will help ensure Almac Clinical Services internal systems are compliant with current Global regulations. The ...
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