Senior Manager, Quality

ESSENTIAL DUTIES AND RESPONSIBILITIES

KEY RESPONSIBILITIES

• Lead the Healthcare QMS implementation and maintenance in the responsible branches.
• Author, review and approve local QMS documentation including procedures, operational standards, working instructions, guides etc.
• Ensure availability of all local and international certificates and licenses required for handling healthcare products.
• Effectively manage non-conformities and customer quality complaints through adequate investigations and root cause analysis.
• Ensure healthcare facilities and IT systems are adequately qualified and validated.
• Participate in Self-inspections, Customer audits, Regulatory inspections, and certification audits. Ensure timely and adequate corrective actions are put in place.
• Perform audits of business partners and ensure quality technical agreements are in place with all approved business partners.
• Make sure data integrity requirements are met and all QMS documents and records are adequately handled and stored.
• Report quality status and related metrics to local and global healthcare management.
• Identify training needs and working closely with local quality managers, develop a consistent and effective training plan.
• Regularly exchange information with Country/Branch Managers to continuously improve quality culture and compliance. Share best practices with other countries/branches.

• Degree in pharmaceutical or life sciences
• At least 5 years of experience working in a pharmaceutical quality assurance function.
• Experience working in a 3PL environment.
• Experience leading site quality operations
• Healthcare regulatory experience, including GDP, cGMP, FDA/ DEA requirements.
• Strong communication and presentation skills
• Good interpersonal skills with the ability to communicate with functions at different levels and regulatory authorities.
• Knowledge of document control systems and procedures and good proficiency with Microsoft office tools.
• Ensure availability of all local and international certificates and licenses required for handling the healthcare products.

• Good proficiency in Microsoft office tools
• Good understanding of computerized system validation in GxP environment

Language Skills:

• English (reading, writing, verbal)
• Interpersonal communication and language skills (e.g., listening to others, speaking to others, reading, writing)
• Communication (facilitation skills and very mature communication skills to be able to communicate to all levels in the organization)
• Strong executive presence and ability to simplify complex concepts for consumption by non-technical executives.

Mathematical Skills

• Good mathematical skills
• Financial acumen

Other Skills:

• Experience in leading and/or working with cross-functional teams from design through the implementation.
• Must be able to work in unregulated temperatures within the warehouse during the warmer and colder months can range from mild to moderate.
• Work overtime as dictated by business whether mandatory or voluntary.

CORE COMPETENCIES

PHYSICAL DEMANDS

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this position description and/or assign tasks for the employee to perform, as the Company may deem appropriate.