At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are Adalvo! 🎯 🚀

We are looking for a Director, QA to join our dynamic team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.

SUMMARY OF POSITION

This position will support all functions according to the legislation with regards to all Quality related activities at Adalvo.

ORGANIZATION STRUCTURE

The Director Quality Assurance will report directly to the SVP, Quality and will support various functions within the organization.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

Provide leadership and oversight and management of the Quality Assurance activities in Malta to ensure GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance.
Promote a quality culture throughout the organisation.
Continuously evaluate Adalvo operations in Malta and make quality and operational improvements as needed through the local management, so as to ensure that all operations comply with all requirements to satisfy the regulatory requirements in the markets in which Adalvo companies operate and as requested by Adalvo Group.
Work closely with all other Adalvo Teams, worldwide as required.
Assist with new product introduction and technology transfer and supporting registrations.
Monitoring and reporting on the effectiveness of the Quality Management System. Work to define, and then review, the agreed Key Performance Metrics monthly as required to Adalvo Corporate Quality management and monitor performance and help identify improvement and effectiveness activities.
Keep abreast of the requirements and the latest trends in GMP and attend suitable training to meet those needs.
Provide training to staff on site on GMP and GDP and monitor people’s training plans for GMP and GDP compliance.
Prepare, review, and approve Standard Operating Procedures (SOPs), batch instructions, testing instructions, and records, and other necessary GMP and GDP documents, for activities related to Adalvo Malta operations, and support Adalvo Corporate SOPs and policies.
Review Technical Agreements with 3rd Parties as required, and work with Adalvo Corporate Quality as needed.
To provide wide-ranging support to the Adalvo Group Quality Team and other personnel in Quality and Operations as needed.
Lead the Adalvo Malta organization through any required regulatory, customer, and external audits.
Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations.
Approval and monitoring of the manufacturing and control conditions at contract manufacturers and testing facilities, through audits, or other means, including due diligence work as required.
Follow up on any Corrective Actions from audits and ensure they are closed out.
To assist with the collection for review of 3rd party batch processing, batch packaging, and analytical records of the pharmaceuticals manufactured for the company as required.
Overall review of the quality systems for management of Adalvo Malta, and at 3rd Party manufacturing facilities and other supplier facilities located in the region.
Assist VP in the management of budgets for the Malta quality organization.
Upon purchase of goods to require documents to support the quality and origin of the batches.
In cases with narcotic medicinal products to acquire and maintain the license for distribution of such medicinal products.
Organizes the process of blocking and withdrawal from the market of batches of medicinal products or medical devices which showed non-compliance with the quality requirements.
Assist with the preparation and approval of Standard Operating Procedures (SOPs) for activities related to this Malta operation. Control and monitor the compliance with the SOPs for all activities related with the warehouse function.
Preparation of programs for corrective actions after inspections conducted by regulatory bodies, other external organizations, and Adalvo Quality audits. Follow up on any Corrective Actions from audits and ensure they are closed out.
Keep abreast of the requirements and the latest trends in GDP and attend suitable training to meet those needs.
To provide wide-ranging support to the Adalvo Quality Team and other personnel in Quality and Operations as needed.
Participation in the management and investigation of complaints and recalls.
Ensure compliance with the EU Directive on Falsified Medicines.
Any other quality management activity that is reasonably requested by management..
Follow relevant GDP &GMP required related to distribution and importation activities.

QUALIFICATIONS & REQUIREMENTS

Education - University degree in pharmacy, chemistry or another science based discipline (minimum Bachelor’s degree). The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry.
Professional experience – preferably not less than 5 years of uninterrupted work experience in the production and/or control of pharmaceuticals.
To be well acquainted with the European standards on Good Manufacturing Practice (EU-GMP) and Good Distribution Practice (GDP), as well as other international GMP standards.
Good command of English.
Good computer skills

CORE COMPETENCIES

Business Focus
Drive for Results
Building Team Spirit
Customer Service
Embracing Change

Why join us?

🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.

🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!

Please be informed that only selected candidates will be contacted.

Director of Quality Assurance

Job Description