Quality Assurance Manager Job

Date: Apr 10, 2019

Location: Milton Keynes, ENG, GB

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Requisition ID: QUA008567

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:



  • Supported by the Quality Systems Manager and Qualified Persons located in Milton Keynes, provides full Quality Assurance support to the Milton Keynes site operations.



  • Ensures that the Milton Keynes Quality Compliance (IPT1 Compliance) function operates in a safe manner and that all staff are suitably qualified and trained to undertake the tasks assigned to them.



  • Manages the Milton Keynes IPT1 Compliance function and work with the Qualified Person(s) to provide an efficient and effective service to support the timely and compliant release 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 all of 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 needed during the technical transfer of products into and out of the site.



  • Working with the Quality Systems Manager ensures that the Quality Management System (QMS) in use at the Milton Keynes site is fit for purpose.



  • Acts as the point of focus for all 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) regarding the 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.



  • Deputises for the Head of Quality as required and if needed for other Quality Compliance managers.


 

Duties, Responsibilities, Activities

 

 

Management



  • Ensures that hazards from work operations including the working environment are identified, that risks are understood and controlled and that where appropriate effective control measures such as guards and/or personal protective equipment are available, maintained and used.



  • Ensures that all IPT1 Compliance staff are suitably empowered and fully engaged with other business functions and that appropriate processes and systems are established and maintained to ensure the efficient, effective and compliant support of site (and global) operations.



  • Ensures that standard operating procedures including safe systems of work are developed and approved for all activities and operations undertaken by IPT1 Compliance staff.



  • Recruits, trains, coaches and mentors suitably qualified and knowledgeable people to ensure that they are able to carry out their duties and tasks in a compliant and safe manner in accordance with the relevant approved procedures.



  • Coordinates and organises the efficient review and approval of records and data to support the timely release of intermediates and products to meet the needs of production, the supply chain and other internal customers.



  • Contributes as required to ensure timely completion of Product Quality Reviews.



  • Where inspections and audits of the sites are undertaken ensures that any adverse observations or findings are thoroughly evaluated and suitable CAPAs implemented and closed out in a timely fashion to fully address the deficiencies raised.



  • Reviews and approves protocols, reports, SOPs, and other documents as needed



  • Communicates effectively with the team, senior management and internal customers and stakeholders.



  • Reports and manages performance metrics in a timely and effective manner.



  • Ensures regular safety monitoring of the IPT1 Compliance facilities are undertaken as needed.



  • Ensures that accidents and incidents are fully investigated and documented, that near misses are recorded and that appropriate CAPAs are put in place so as to prevent the occurrence/recurrence of such events.  Also ensures that the SHE department is advised of all statutory reportable events.



  • Ensures that the IPT1 Compliance team understand and comply with all relevant work-related legislation and regulatory standards; including the relevant Health, Safety, Environment, Medicines GMP, Home Office and Employment legislation relevant to the operations and duties they undertake.



  • Conducts regular performance reviews of the IPT1 Compliance team, including appropriate role, project, and GMP/HSE compliance aspects against agreed objectives and to set targets.



  • Manages the IPT1 Compliance expenditure and headcount to agreed targets.


 

 

Leadership



  • In all activities is a role model for the successful implementation of the MSD Corporate Policies and MSD Leadership Behaviours such that they become the shared mindset of the Quality Function.



  • Focuses the team on Quality Systems thinking and continuous improvement.



  • Provide coaching and support for all team members in setting and achieving realistic development goals aligned with career aspirations and potential.



  • Leads and models the partnership with Global Supply Chain, Global Quality, Partner sites within the network and other stakeholders towards full, open, inclusive and effective engagement in achievement of site and global objectives.



  • Engages with external authorities and stakeholders to deliver outcomes in best interest of the company and its patients.


 

 

Technical

 



  • Provides technical/scientific/GxP advice and guidance as required.



  • Supports the sites to improve Right First Time (RFT) and process capability as well as drives improvements to the QMS.



  • Supports the implementation and use of Lean Sigma and Class A throughout the sites using data to drive continuous improvement.



  • Provides active support and, as required, conducts investigations into deviations and Out of Specification/Tolerance (OOS) events.

Qualifications

Ideal Background

 

 

Minimum Experience Required:



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



  • 5 years supervisory or management experience.

 

Skills/Knowledge Required:



  • Degree in Chemistry, Biology or biosciences field.



  • Experience as a Project License Holder preferred.


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



  • Excellent interpersonal skills including good communication, conflict management 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 GMP Related
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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