Manager, Quality

Responsible for leading implementing and improving Quality Management Systems (QMS) at manufacturing sites ensuring regulatory compliance (FDA ISO EU MDR MDSAP GMP) and alignment with internal policies and corporate standards. Supervises multidisciplinary quality teams promotes a culture of continuous improvement manages risks audits processes and supports adaptation to new regulations. This role is key in ensuring product quality patient safety customer satisfaction and achieving the companys strategic business objectives.

Main Functions and Responsibilities:

• Lead and supervise Quality Assurance / Design Assurance / Quality Compliance / Quality Systems teams managing development training resource allocation and coaching.
• Establish maintain and improve the QMS including documentation procedures CAPA DHR change control specification management and training.
• Manage internal and external audit programs (FDA ISO local authorities) prepare responses action plans and follow-up of findings; act as quality representative during regulatory audits.
• Implement and administer risk management systems and resolve non-conformities (NCMR CAPA Post-Market Surveillance).
• Ensure regulatory compliance with applicable regulations (21 CFR 820/803/806/411 ISO 13485/ISO 14971 MDSAP EU MDR/GMP/SOX).
• Lead integration and deployment of digital systems and process improvement projects digitalization and operational efficiency.
• Monitor analyze and report key quality metrics trends and compliance status.
• Influence and collaborate with cross-functional teams (Manufacturing R&D Regulatory IT Engineering); act as technical reference for root cause analysis validations failure investigations and risk management.
• Manage appropriate allocation of material and human resources for quality process compliance.
• Ensure compliance with EHS requirements and support a culture of safety and continuous improvement.
• Represent the quality area in strategic committees and management review meetings.
• Promote an inclusive excellence-focused and improvement-driven culture ensuring recognition and motivation for the team.
• Stay updated on new regulatory standards; develop and implement plans to adapt the QMS as needed.
• Direct and ensure proper operation of specialized areas (Microbiology laboratory CAPA audit document center validations returned product analysis).
• Undertake additional responsibilities as assigned by senior management to achieve corporate objectives.

Qualifications :

Key Requirements and Qualifications:

• University degree in engineering sciences chemistry biology or related field; postgraduate degree preferred.
• 510 years of experience in quality roles in the medical/pharmaceutical/biotech industry with at least 25 years in management/leadership positions.
• Deep knowledge of QMS FDA regulations ISO 13485/ISO 14971 MDSAP GMP EU MDR and similar standards.
• Strong experience in auditing CAPA management document control validations and risk management.
• Proficiency in English (oral and written); ideally bilingual Spanish.
• Quality certifications (CQA CQE Green Belt Risk Management) preferred.
• Advanced leadership project management communication problem-solving and team development skills.
• Proficient in IT tools (MS Office QMS platforms) and digital quality systems.
• Ability to manage multiple projects prioritize and build consensus in multicultural and cross-functional environments.

Additional Information :

At AbbVie we are committed to cultivating a workplace culture that promotes inclusion diversity and personal growth. We recognize that our collective success is based on the individual well-being of our employees which is why we have designed a benefits package that considers every aspect of their lives.

• Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance ensuring peace of mind for you and your loved ones. 
• Extended Vacation: We believe in the balance between work and personal life for our administrative team. Thats why we offer additional vacation days beyond legal requirements. 
• Flexible Hybrid Work Model: For eligible positions within our administrative staff we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.
• Life Insurance: Secure your familys future with our life insurance policy.  
• Employee Assistance Program (EAP): Access professional support with our comprehensive EAP offering psychological legal and financial counseling.
• On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services demonstrating our commitment to your health and well-being. 
• Community and Social Engagement: Make a difference with a paid volunteer day allowing you to contribute to the community during company working hours. 
• Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off. 
• Employee Stock Purchase Plan: Participate in our companys success by purchasing shares at a special price exclusive to employees. 
• Transportation and Meals subsidized. 
• Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time