Head of QA Manufacturing Operations

仕事内容

Site Name: Belgium-Wavre

Posted Date: Feb 4 2022

‘Be You’ at GSK.

At GSK, we’re a company with a purpose to help people do more, feel better and live longer. We realize that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively.

Head of QA Manufacturing Operations

In this role you will…

Strategy And Direction

• Lead the Belgium Quality Assurance Manufacturing Operations Leadership team including all QA MPU heads, define the Manufacturing Operations Quality Strategy and contribute to the definition of the Sterility Assurance strategy for Manufacturing Operations to meet the business objectives of GSK Vaccines.
• Operate as BOLT member (Belgium Operations Leadership Team), and as a Leader of the Manufacturing Operations Leadership Team in order to achieve the short, medium and long term business targets and Quality standards and ensure facilities are managed in accordance with GSK Vaccines and GSK quality standards and ensure compliance with GSK Vaccines standards policies, procedures and local regulations.
• Provide leadership on Data integrity within Manufacturing Operations and provide coaching and influence of Belgium Operational partners to build and sustain a Quality Excellence Mindset drive a Quality Culture with a focus on Predict and Prevent.
• Ensure alignment of respective Manufacturing Quality Units with the strategy, objectives and policies of Belgium Quality assurance and quality systems.
  

Manufacturing Operations And Quality

• Lead QA Manufacturing Operations. Put in place a mechanism to monitor and improve business unit quality performance through Key Performance Indicators related to Quality, Budget, Deviations, CAPAs and Change Control.
• Be proactive in anticipating potential improvements of the current quality processes while assuring compliance with the Change Management Procedures.
• Ensure the flexibility of manpower workforce to achieve customer satisfaction and cost targets in the short, medium and long terms in managing downsizings and / or headcount increases.
• Work collaboratively with the quality systems group to realize synergies, deliver best Quality practice and consistency of approach.
• Develop improvement plans to ensure ongoing compliance with future requirements. Responsible for the representation of Manufacturing Operations activities during external audits (FDA, WHO, National
• Health Authorities etc.) and act as the Vaccines responsible person during regulatory audit such as FDA, to avoid significant impact on vaccines business and interruption to supply.
  

Change And Process Management

• Provide leadership for change initiatives involving processes, technologies and people which contribute to the overall effective improvement of GSK Vaccines Quality.
• Build continuous improvement capabilities, share, and integrate best practices within the Vaccines Quality Network.
  

People Management And Development

• Focus on People management, succession planning and team development to ensure the retention. Lead, train, coach and motivate management team and employees towards Continuous Improvement, Good Manufacturing Practices, and provide active development of direct reports and key talents within the Manufacturing Operations organization network to create high performing team.
• Manage a significant number of people through effective performance management and labor relations excellence.
  

Why you?

Qualifications & Skills

• Bachelor’s degree in manufacturing/science, engineering or quality.
• Substantial experience in Quality roles within a pharmaceutical / sterile operations / biological production environment.
• Excellent knowledge of regulatory, GMP, sterile manufacturing and legal requirements relating to QA; deep knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections.
• Executive and leadership capability to manage people.
• Excellent English and French spoken and written skills.
• Strong Interpersonal skills and a developed knowledge of data integrity.
  

Preferred Qualifications & Skills

• Master’s degree is preferred.
  

Application Details

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please submit a cover letter with your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information provided in your cover letter and CV will be used to assess your application.

Closing date for applications: 20th of February 2022

Thank you for your interest in this opportunity!

If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please contact your local HR department.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, 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.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.