LOC Quality Manager - Pharmaceuticals

Basic qualifications:

Education and Experience:

  • Successful completion of relevant tertiary scientifically-based qualifications
  • Minimum of 5-8 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager
  • Strong understanding of and experience in Pharmaceutical Quality Assurance systems particularly in the areas of product release, deviation handling, incident management and conducting audits
  • Strong knowledge of the local regulatory landscape and regulatory requirements pertaining to GMP/GDP
  • Good knowledge on effective quality documentation systems

Preferred qualifications:

Essential Skills and Abilities:

  • Excellent communication and interpersonal skills and abilities
  • The successful candidate must have demonstrated strong leadership and influencing skills
  • Professional written and verbal communication skills
  • Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
  • Ability to influence and motivate stakeholders at any level of the LOC organization

Analytical mind, good attention to detail and problem solving skills within a structured process

  • Good team player – works well in cross-functional teams
  • People management and development skills

Good time management skills, with ability to multi-task and work under pressure

Concise and persuasive in the description of the different QA situations

  • Able to stick to the standard and not be pressurized
  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
  • Flexible thinking – able to challenge and see views from different perspectives
  • Ability to self-motivate and be resilient and focused under pressure
  • Able to effectively enable and drive change across cross functional stakeholders
  • Strong general computer literacy with Intermediate skills in MS Word, Excel, Power Point and Outlook
  • LI-GSK

Details:

The job exists within the commercial Rx Local Operating Companies to ensure that the mandated

GSK Quality Management Systems requirements for commercial operating units are met. The

function is critical to the effective management of systems and activities that are crucial or have

a direct impact to product quality and regulatory compliance. The job holder is expected to take

the lead in implementing and sustaining the QMS (insert LOC Name) Rx, including encouraging

the Commercial Rx business to own quality activities in their day to day work.

KEY ACCOUNTABILITIES / RESPONSIBILITIES :

Quality Strategy

  • Key market contact and responsible person for all QMS activity and issues, relating to the

commercial business.

  • Assess and proactively create and implement a continuous improvement plan for the adoption

of the principles and requirements of a Quality Management System into the commercial

business, includes identifying, understanding and sharing appropriate information.

  • Heighten and promote quality and QMS awareness in the commercial business functions.

Engage and assist relevant stakeholders in understanding and generating appropriate systems,

processes and policies, as required within defined areas of the business, in compliance with

QMS principles.

Build strong relationships across the LOC Commercial Business functions and work with them to

develop quality objectives that meet both business and regional quality objectives. Undertake

relevant training forums to deliver QMS knowledge to relevant parts of the business enabling

them to identify, incorporate and deliver on relevant quality objectives.

Maintain a high level of QMS knowledge and awareness of changes within the commercial

environment to seek opportunities and manage potential business adversity.

Develop a network to obtain local regulatory intelligence and provide the necessary analysis

to understand and escalate issues which have the potential to impact supply or GSK's

reputation.

Act as the relevant LOC quality contact for the Regional Quality organisation providing

communication to the regional quality organisation on progress on QMS compliance status

updates on quality plans and escalation of issues. Share learning's and issues appropriately with

other LOC and regional colleagues.

Gain understanding of the high level business plans of the LOC as they potentially link to quality

– ensure any quality activities are identified and defined in the annual quality plan.

  1. Quality Systems

Responsible for the ensuring a robust, sustainable and effective QMS (Quality Management

System) through monitoring and reviewing the compliance status within the (Local insert LOC

Name) Marketing Company.

Implement and maintain effective Quality Assurance systems to ensure that local operations

are in full compliance with GSK standards and policies, Guide for Commercial Companies

  • GMP, GDP and regulatory requirements by performing the following:

o Ensure that all SOPs are in place, updated & training has been conducted across the

business. Ensure a monitoring system in place for tracking training compliance and

process for escalation of persistent non-compliance. Processes in place for delivering

routine training for updates to SOPs, GQPs, GQMPs as relevant.

o Promote QMS management principles and seek continuous improvement of the

processes

o Review, conduct impact assessments and implement any updates to QMS policies

o Manage QMS Management Review meetings according to local SOPs

o Identify, Implement and Manage QA Objectives & KPIs

o Establish and manage Annual Quality Plans

Ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS,

Guide for Commercial Companies and local regulatory requirements, including (but not limited

to)

o LOC Quality Council in place with regular meetings and including all relevant business

functions. LOC Quality Council format, frequency and reporting standardised to global

requirements. Quality metrics and reporting format/ system in place with oversight and

review during LOC Quality Council

Contact information:

You may apply for this position online by selecting the Apply now button.

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