Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
In our global EMQA Team we are looking for:
External Manufacturers Quality Assurance Manager
Location: Poland ( Remote work)
Overview:
Bausch Health is currently looking to fill a new role for External Manufacturers Quality Assurance Manager (EMQA). Our External Manufacturing Quality Assurance (EMQA) team plays a critical role in ensuring that our global network of contract manufacturers meets the highest standards of quality, compliance, and regulatory excellence. As the External Manufacturing Quality Assurance Manager, you will be responsible for overseeing the quality performance of external manufacturing partners, ensuring compliance with GMP standards, and driving continuous improvement across the supply chain. You will collaborate cross-functionally with internal stakeholders and external partners to uphold product integrity and regulatory compliance.
Key responsibilities:
The deliverables of the External Manufacturers Quality Assurance Manager, within are:
- Act as the primary Quality contact for assigned external manufacturing sites.
- Ensure external partners operate in compliance with EU GMP, ICH guidelines, and internal quality policies.
- Conduct periodic quality reviews and performance assessments of external manufacturing partners.
- Lead and support the investigation of quality incidents, deviations, and complaints related to externally manufactured products.
- Evaluate and approve change controls impacting externally manufactured products. Collaborate with cross-functional teams to assess quality and regulatory impact.
- Support product transfers, launches, and discontinuations from a quality perspective.
- Ensure timely and compliant batch release in coordination with Qualified Persons (QPs) and regulatory teams.
- Drafting and maintaining agreements with external manufacturers.
- Participate in audits and provide support during inspections. Follow up on audit findings and ensure timely closure of observations.
- Monitor and report quality KPIs for external manufacturing sites. Identify trends and areas for improvement; lead initiatives to enhance quality performance. Promote a culture of continuous improvement and proactive risk management.
- Work closely with Regulatory Affairs, Supply Chain, Technical Operations, and Legal to ensure alignment on quality-related matters.
- Stay current with evolving regulatory requirements and industry best practices.
- Assess impact of new regulations on external manufacturing operations and update procedures accordingly.
Requirements to the candidates:
The following attributes are necessary:
- Bachelor’s degree or equivalent in Chemistry, Master of Science/ Pharmaceutical Chemistry or equivalent academic/vocational training.
- Previous experience role a bonus but not necessary.
- Strong knowledge of EU GMP, cGMP, ICH Q10.
- The candidate should have knowledge of executing quality systems elements related with Pharmaceutical regulations and requirements
- Medical Devices experience is a bonus but not necessary
- Suitable experience that would provide the knowledge, skills, and abilities to perform the job as described.
- Able to comply with all relevant SOPs and/or internal requirements.
- Experience with Excel, Word, Electronic Document systems, and/or file sharing applications required.
- Must be action oriented, make informed decisions and be self-motivated
- Working knowledge of applied statistics, quality systems and regulatory requirements.
- Ability to detect and resolve problems, own decisions, and accomplish tasks/goals.
- Ability to quickly identify escalation needs.
- Ability to travel as needed to external manufacturing sites.
- Time management, project management and data analytics skills are desired.
- Excellent verbal and written communication skills, detail oriented, and ability to work productively in an interdisciplinary team environment.
- Fluent in English (oral and written).
We Offer:
- Working in global organization.
- Pleasant working atmosphere in international environment.
- Opportunity for learning and growing in positive and supportive team of professionals.
We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.