Quality Assurance Operations Manager - Combined Products

At Adalvo, we're not just a company - we're a team of passionate individuals 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 an enthusiastic Quality Assurance Operations Manager to join our dynamic Quality s 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 calls for an ambitious individual with a strong knowledge and experience in Drug-Device Combinations Products and Medical Device (including but not limited to pre-filled syringes and single/multi dose injection pens) who will support the Quality Operations team at Adalvo to ensure effective and continued quality oversight of third party contract manufacturing organizations, API suppliers and other service providers in compliance with applicable regulatory requirements. The candidate will also have an active role in supporting the Quality elements associated to product development projects as well as technology transfer and process improvements.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Be the Quality Operation Subject Matter Expert (SME) in Drug-Device Combinations Products and Medical Device and ensure full compliance of Adalvo products/projects to relevant regulations , guidelines and standards (including but not limited to MDR 2017/745/EU, US 21 CFR and US QMSR , EN ISO 14971, EN ISO 13485, UNI ISO/TR 24971).

• Assist with new product introduction, development and technology transfer and supporting regulatory registrations.

• Execute quality audits at Suppliers\CDMOs and guarantee the implementation of the agreed CAPA plan

• Preparation/negotiation of Quality Agreements with 3rd parties.

• Support Suppliers\CDMOs with Regulatory Inspection and preparation corrective and preventative actions (CAPA) after inspections

• Contribute to Suppliers\CDMOs development with GMP training and coaching

Review and approve all the quality documentation related to the development projects and\or the Technology Transfers like:

• Raw materials and Finished Products specifications.

• Master Batch Record.

-Process Validation Plan\Protocol\Report.

-Executed Batch Records.

-Cleaning Validation.

-Packaging Validation.

-Nitrosamines and elemental impurities risk assessments.

-Elemental Impurities Assessment.

-Aseptic Process Simulation (APS) Protocol\Report.

-analytical methods validation and transfers.

-Change Control.

-OOS\OOT\Deviations.

• Any other document related to the manufacturing and testing of the product in scope

• Support due diligences for the evaluation of new product dossier/partners as relevant to the scope of role function

• Perform oversight and management of the Quality Assurance activities related to CDMO/service provider operations to ensure GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance.

• Collaborate with CMO/Service provider in the management and investigation of complaints and recalls.

• Liaise with CMO/service provider in the communication of changes impacting registered dossier to Adalvo customers.

• Continuously evaluate CDMO/service provider operations and recommend quality and operational improvements as needed, to ensure that all operations comply with all regulatory requirements and product quality, safety and efficacy for intended markets.

• Keep abreast of the requirements and the latest trends in GMP, GDP and other regulatory requirements and attend suitable training as required.

• Monitor and report the effectiveness of the Quality Management System at CMO/Service provider.

• Work closely with all other Adalvo Teams worldwide as required.

• Support training of personnel on GMP and GDP

• Promote a quality culture throughout the organization.

• Assist in the management of budgets for the Quality Organization.

• Support the Quality Assurance department in the conduct of quality risk assessments.

• Support any other quality management activity that is reasonably requested by management.

QUALIFICATIONS & REQUIREMENTS

• Education - University degree in pharmacy, chemistry or another science based discipline (minimum Bachelor’s degree).

• Professional experience – preferably not less than 8 years of work experience in the production and/or control of pharmaceuticals.

• Well acquainted with the European standards on Good Manufacturing Practice (EU-GMP) and Good Distribution Practice (GDP) as well as other international GMP standards.

• Strong knowledge and experience in Drug-Device Combinations Products (including but not limited to pre-filled syringes and single/multi dose injection pens) and Medical Device regulation, guidelines and standards

• Experience in Experience with Regulatory Inspections EMA, FDA, Russia, ANVISA, etc.

• Experience with oral dosage forms (tablets, capsules, etc.) and injectables

• Experience in conducting audits

• The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry.

• Good command of English.

• Good computer skills

CORE COMPETENCIES

• Quality

• 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!

Kindly be informed that only selected candidates will be contacted.