Deputy Site Quality Head Job

Date: May 31, 2019

Location: Milton Keynes, ENG, GB

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Requisition ID: QUA008566

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 

 

Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


 

 

Position Overview:



  • Deputising to the Site Quality Head, the deputy Site Quality Head will work directly with, and act on behalf of, the Site Quality Head during site absence.



  • Working with the IPT Quality teams, Quality Systems team, Quality Control teams and Qualified Persons located at UK sites, provide Quality Assurance support to the UK site operations.



  • Take on ownership, directly and indirectly of key quality systems, driving compliance and continuous improvement.



  • As required act in Quality Management roles within UK quality operation, across Quality Systems, IPT Quality and Quality Control. 



  • Work directly with IPT staff, supporting and at times leading significant investigations to provide an efficient and effective service to support the timely and compliant disposition of materials, components and products.



  • Working with the site management, ensures that the Milton Keynes site operates in a fully GMP compliant manner in accordance with the relevant corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported.



  • Partners with and supports other sites and functions as required, e.g. during regional improvement activities, during the technical transfer of products into and out of the site, or during cross site investigations.



  • Acts as site representative for compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory Inspections.



  • Either directly or through the QP, liaises with the Veterinary Medicines Directorate (VMD) and other relevant HA’s regarding the routine and non-routine release of biological products and at other times to secure the resolution of complaints and other issues that might impact the quality and supply of the products supplied by or for the company.



  • Participate in and where required lead escalation and issue resolution processes relating to significant regulatory or quality events that require concurrence above site.



  • Provide leadership and coaching to both quality and production staff in relation to quality performance and improvement.

Qualifications

Minimum Experience Required:

 



  • 8 years post graduate experience in pharmaceutical manufacturing either in a QA or QC role.


 

Skills/Knowledge Required:

 



  • Degree in Chemistry, Biology or biosciences field



  • Proven technical ability including: knowledge of GMP/GCLPs, QMS, test method validation & equipment qualification, Lean and 6 Sigma, continuous improvement/business excellence.



  • Excellent Leadership and interpersonal skills including verbal and non-verbal communication, stakeholder management, conflict management, issue resolution and leadership.


 

 

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


 

 

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Law, Lean Six Sigma, Pharmaceutical, Supply, Healthcare, Legal, Management, Science, Operations

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