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CMC & Technical Quality Systems Manager Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Onsite
Onsite Location(s): 

Cork, C

Location: Cork

Req Number: 520272 

 

 

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 


Position Statement

 

 

This position has the primary function in providing Chemistry and  Manufacturing Controls (CMC) expertise for the Pharmaceutical Quality System (PQS) and leading the Technical  Quality function: Specific responsibilities include, but are not limited to the following.

 
 
Key Responsibilities
 
  • Leadership of the CMC and Technical Quality function for BSC Pharmaceutical Products to include API’s, Commercial products, and Clinical supply products. This will include the support of the strategy for Process and Analytical method development for the active pharmaceutical ingredient (API), excipients, Pharmaceutical products, and the Design assurance process for the medical device elements of the Pharmaceutical led combination products.
  • Support in the development, management and compliance of the Pharmaceutical Development process and procedures in alignment with the Pharmaceutical Regulatory requirements.
  • For the processes lead by the CMC and Technical Quality function ensure the PQS is compliant to ICH (Q8, Q9 and Q12A.) and the  GMP’s of all pharmaceutical and combination products regulatory agencies (e.g., FDA, EU,PICs )
  • Governance of the Risk management process for Pharmaceutical products in accordance with the PQS, which includes the control of the critical process parameters (CPP’s), critical quality attributes (CQA’s) and PFMEA documentation by facilitating cross-functioning planning of activities.
  • Supporting regulatory submissions (Investigational New Drug Applications (IND), Investigational Medicinal Product Dossier (IMPD), new drug application (NDA), Biologics License Application (BLA)), including preparing CMC sections, Product Stability program strategy and ownership of post market commitments.
  • Support Project management in the development of the timelines and budgets for CMC and Quality technical projects including timing of the submissions in conjunction with Regulatory
  • Support Pharmaceutical Products complaint investigations.
  • Support the Pharmaceutical Production Unit process improvements and optimisations  to assure robust and scaleable manufacturing processes that meet product target profile/specifications.
  • Support the development and optimization of analytical methods and protocols and ensure methods and techniques are in compliance with the PQS.
  • Support Supplier Engineering for projects related to Product Adminstration kit, including Vendor Management.
  • Liaison with production operation teams, R&D and Regulatory on component quality issues and supplier initiatives for the API  and  varithena adminstration kit components.
  • Support other projects as assigned by the company.
  • Deliver project status updates to senior management and project sponsors incorporating status reports and project plan updates.
  • Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Pharmaceutical Quality System and the appropriate regulations for the area they support. 
  • Ensure employees are trained to do their work and their training is documented.

 

Education & Experience Requirements

 

  • Life Science Bachelor’s Degree with a sound technical background
  • 5 Years+ experience in pharmaceutical development and manufacturing
  • Excellent understanding and hands -on working  knowledge of cGMP, quality and regulatory requirements for clinical and commercial material
  • Demonstrated ability to successfully  manage a team for technical transfer and pharmaceutical development projects

 

#IJA

 

About us

 

Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth

 

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.

 

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran


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