Global Business Process Owner – Complaint & PIRC

Job purpose:

As an enterprise level Global Business Process Owner, you will be responsible for forming the strategy and process for the quality complaint and PIRC process.  You will review data from systems and users to diagnose where change is needed and implement cross functional organisational change projects which improve business performance.  In this role, you will act as Council Chair to collaborate with key interface partners to maintain, sustain and continuously improve process and associated tools and technologies.

You will have accountability for the standardization of the procedures that continue to increase quality culture and performance in alignment with the regulatory authority expectations. You will also provide governance of operational area leads (GSK Site, LOC, Warehousing, Distribution Centres etc) compliance with Good Manufacturing Practices (GMP), by trending the key performance indicator for your process.

In this role you will…

• Drive standardization, innovation, and compliance for end to end (E2E) process across the network

• Be responsible for the process policy and GSOP, application, data and digital solutions associated with the process.

• Lead/facilitate community of practice (CoP) across the network

• Support audit findings and preparation on topic, act as an audit coach as needed

• Represent GSK in external advocacy and sharing best practices.

• Drive the implementation needs: training of sites, support of gap/implementation assessment, tackling barriers to successful implementation at sites/LOCs

• Liaise with site SMEs throughout the process: impact assessment, design, review, implementation.  Responsible for ensuring the SME list is accurate.

• Knowledge of global regulations and guidance, global regulatory and pharmacopeial expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise

• Define deployment strategy within GSK (QMS direct to LSOP or GSOP/Technical Standard) and have it endorsed at QMS Tier 1, or Quality Tier 2/3 Quality Council governance forums.

• Design the global standard operating procedure when required, in collaboration with One Quality QMS executive.

• Drive simplification of the process, design the training packs and capability across network

• Develop the key performance indicators, global data review and trending of the KPI providing a mechanism for oversight of products manufactured in multiple locations/sites

• Be responsible for optimizing the tracking processes and records within QWF/MERPS and Veeva QMS system as required

Why you?

Qualifications & Skills:

• Minimum Bachelor Degree, Master of Science or PhD in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge

• Extensive experience in pharmaceutical/ vaccines manufacture, release & distribution.

• Good understanding of ICH Q10 Pharmaceutical Quality Systems

• Good understanding of how the topic/QMS process is implemented within global supply chain.

• Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise.

• Fluency in English

Preferred Qualifications & Skills:

• Excellent written and verbal communication skills. 

• Ability to work across many different cultures, functions and manufacturing/ distribution operational areas£

#Li-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. 

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