Manager Csv- QA Operations

Our client is a biopharmaceutical company

This position works closely with the Leadership Team, QA Direction included, to identify and handle process quality and cGMP compliance related issues as well as to contribute to process improvement in his/her scope of activity.

The Manager QA Operations can act as the back-up of his peers or direct reports.

Main Responsibilities:

- Is responsible for directing, coaching and supervising the assigned personnel in direct line.
- Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Provides continuous support and adequate coaching to ensure direct reports fulfill their duties and objectives. Assures continuous professional development and guidance to direct reports.
- Manages projects activities and ensures appropriate team members are assigned to appropriate activities.
- Handles the recruitment process of new team members according to current and planned workload.
- Handles deviations, CAPA, and Change Control related to Computerized Systems and to ensure the execution and to ensure the execution and the follow-up of escalation processes.
- Represents and leads QA Operations for the site through the initiation and implementation of new projects.
- Reviews and approves procedures and projects documents as QA approver.
- Facilitates and participates to Data Integrity Risk Assessment for assigned systems & processes, definition and follow-up of remediation action plan.
- Provides support and guidance to other departments and functions for Data Integrity topics.
- Supports Health Authority inspections by participating to the preparation and to the execution by answering questions and/or providing documentation.
- Supports the internal GMP audits process and the follow-up and the implementation of the internal audit CAPAs.
- Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of the site.
- Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.

Your profile:

- At least 7 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
- BSc/BA or MSc in Science, Computer Science or relevant discipline.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Experience in priorities and people management
- Capability to manage off-site teams.
- Able to drive the development of team members and to motivate them in a highly cross functional, stressful and moving environment.
- Strong understanding of requirements for Computerized System Validation and Data Integrity.
- Strong system and process insight: impact and consequences on compliance, operations and cross-functional areas.
- Good understanding of solid oral dosage form manufacturing/packaging and QC processes.
- Excellent organization, interpersonal and communication skills, including written & oral communication, and training skills.
- Works independently, yet effectively in a team environment, makes proposals and facilitate decision when escalation is needed.
- Excellent investigational skills and QA problem solving skills.
- Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines.
- Sense of responsibility, reliability, team spirit, initiative and service.
- Knowledge of most common office software.
- Excellent team player attitude.
- Ability to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team.
- Strong system and process insight: impact and consequences on compliance, operations and cross-functional areas.
- Strong critical thinking to analyze complex situations and discern critical issues.