Director of Clinical Quality Assurance en Seranbio

The Director of Clinical Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence, ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy.  This position will provide strategic direction and guidance for the Clinical Quality Assurance functions to assure end-to-end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements.  The position is also responsible for ensuring that Quality operates in compliance within internal quality system procedures, mitigation of identified compliance and quality risks throughout product life cycle from development to commercialization for the products manufactured at Serán BioScience.

Duties and Responsibilities

Identifies and eliminates risk to continuously improve customer satisfaction and product reliability

Leads and steers Clinical Quality Assurance (QA) Department, including hires and mentors QA personnel, provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy

Leads implementation and continuous improvement of the company’s quality systems and facility validation

Creates product quality documentation system by writing and updating quality assurance procedures

Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing

Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines       

Documents authorship, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications

Supports internal audits, client audits and regulatory inspections

Provides support and oversight of Quality Management Review meetings

Oversight of a broad range of documentation including, but not limited to User Requirements Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Controls, and Risk Assessments

Maintains product quality by enforcing quality assurance policies and procedures and government requirements

Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods

Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends

Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate in manufacturing and QC

Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget

Responsibilities may increase in scope to align with company initiatives

Other related duties as assigned

Required Skills and Abilities

General knowledge of aseptic manufacturing processes

Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs

In-depth understanding and application of cGMP principles, concepts, practices, and standards

Experience with regulatory inspections by the FDA and EU authorities

Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally

Demonstrated ability to partner with other functional groups to achieve business objectives

Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals

Experience organizing and managing work responsibilities while working independently with minimal oversight

Time and project management skills with the ability to multi-task and meet deadlines

Excellent verbal and written communication skills

Excellent organizational skills and attention to detail

Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company

Accepts feedback from a variety of sources and constructively manages conflict

Strong analytical and problem-solving skills

Proven ability to lead organizations

Ability to prioritize tasks and to delegate when appropriate 

Proficient with Microsoft Office Suite or related software

Education and Experience

Bachelor’s degree in a scientific discipline; advanced degree is preferred.

Requires a minimum of 10 years of GMP and Quality experience in the Pharmaceutical or Biotechnology industry

Requires a minimum of 5 years in a QA management role

Physical Requirements

Prolonged periods of sitting or standing at a desk and working on a computer

Must be able to lift up to 15 pounds at a time

Adheres to consistent and predictable in-person attendance

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