Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR
Bachelor’s degree & 5 years of experience directly related to the job
• Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Completes prioritized work plans
• Quickly advances issues that could impede the ability to close records according to action plans
• Maintains compliance with local and global processes
• Execution of regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides mentorship and technical advice
• Evaluates subject matter specialist assessments
• Raises potential Quality issues to Management
Beyond that, additional preferred qualifications are:
• Experience in quality and manufacturing and/or Product Development/Safety/Research experience in biotech or pharmaceutical industry
• Demonstrated skill in facilitating complex investigations from initiation to completion
• Knowledge of Root Cause Analysis (RCA) process
• Expertise in development management and complex investigations
• Combination products expertise
• Demonstrated ability to deep dive into technical issues and also appropriately manage upward
• Ability to successfully manage workload to timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing, and negotiating.
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development
• Ability to interact effectively with regulatory agencies
• Strong word processing, presentation, database, and spreadsheet application skills
• Excellent communication and executive presence (both written and oral), facilitation and presentation skills
• Strong skill in working independently and to effectively interact with various levels
• Skilled in risk management
• Project management skills
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.
Primary responsibilities include: supporting the product complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
– Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
– Ensure complaint related investigations are concise, clear, and science-based by reviewing and approving such investigations.
– Follow-up on corrective actions derived from investigations through completion.
– On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
– Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
– May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
– Doctorate degree or Master’s degree and 3 years of directly related experience to the job or Bachelor’s degree and 5 years of directly related experience to the job or Associate’s degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
– Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
– Excellent written and verbal communication skills, including facilitation and presentation skills.
– Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
– Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.