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Pharma Quality Manager Job

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Date: Apr 8, 2021

Location: Cork, C, IE

Company: Boston Scientific

Location: Cork, Cork (IE-C), Ireland (IE)
Status: Permanent 
Req ID:476220 

 

We are committed to providing access to opportunities at Boston Scientific for all applicants. If you have a disability and require supported assistance and you would like to talk about potential accommodations related to applying for employment at Boston Scientific Cork, please contact me directly for a confidential discussion corkrequisitions@bsci.com.  Tel No: 021-4531182.

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • 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’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Purpose:

Design and develop an appropriate Quality Organization for the New Boston Scientific Cork Pharmaceutical Production Unit. Lead and support the Pharmaceutical Quality Systems, Quality Control and Quality Operations Team to ensure effective management of the Cork Pharmaceutical Quality area. Develop and support the departmental goals and objectives in line with the overall site and global goals. Lead the governance of all Quality System and Operations metrics for the Pharmaceutical Production Unit.

 

Responsibilities:

 

  • Assist in ensuring understanding and compliance with the requirements of cGMP as applied to the Pharmaceutical Production Unit in Cork, with provision of appropriate training as required.
  • Ensure all necessary processes and controls are in place as required for the disposition of finished product by the Qualified Person including efficient and effective coordination of batch release activities between operations,  manufacturing, batch release team and the Qualified Person.
  • Maintain Inspection Readiness for the Pharmaceutical Production Unit and Quality System and host agency inspections.  Ensure effective coordination of the Pharmaceutical Production Unit Self-Inspection Program, with timely completion of audits and ensuing actions. 
  • Assist with Pharmaceutical Production Unit Quality troubleshooting as necessary and facilitate appropriate escalation. Evaluate quality events ensuring compliance with cGMP and quality standard requirements. Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. Ensure timely and effective actions are implemented and that CAPA effectiveness checks are conducted.
  • Review and approve validation lifecycle documentation to support adherence to the Validation Master Plan and project activities.
  • Participate and support Continuous Improvement for the Quality Team, including updates based on legislation changes. Ensure site understanding and compliance with the requirements of data integrity.
  • Maintain QA Document Control for the Pharmaceutical Production Unit and Quality System.  Manage CAPA/Complaint and Management review boards for the Pharmaceutical Production Unit.
  • Be recognized as champion of behavioral/GMP and cultural initiatives with strong quality related decision making skills demonstrated.
  • People management of direct reports of the Quality Assurance team and Quality Systems Associates and Specialists for the Boston Scientific Cork Pharmaceutical Production Unit. Assign resources and responsibilities, setting direction and identifying priorities. Provide leadership and development to the organisation to maximise effectiveness and provide career development.
  • Participate as a key member of the Quality departmental staff team contributing to the overall effectiveness of the business. Partner closely with the Boston Scientific Medical Device Quality Managers and represent the Quality Department as necessary. Assist QA Director in developing strategies for the quality function. Partner with and support Global and Peripheral Interventions Quality Teams. Control budgets and spending and insure compliance to financial requirements. Insure budgets are accurately established and adhered to.

     

Education & Experience Requirements

  • Level 8 in relevant science discipline (Chemistry, Biology or Medical Technology preferred)
  • Significant experience in drug manufacturing, medical device or biologics industry in Quality Assurance Quality Control or Quality Engineering
  • Demonstrated satisfactory experience in Quality Management
  • Experience with external audit facilitation
  • Demonstrated knowledge of cGMPS, Notified Body, HPRA, FDA Regulations
  • Qualified Person (preferred)

 

About us

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

 

Boston Scientific maintains a drug-free workplace.  Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 476220

 


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