Risk Management & GMP Compliance Manager

Job purpose:

Coordination and risk management amongst MPU. Raises and maintains the status of quality in the organization and enables a company to promote itself as one that provides quality goods and services

Your responsibilities:

• Risk Management:

• Provide expertise & direction within the MPU in evaluating risks and establishing risk Mitigation plans that include measurable deliverables to ensure performance.

• Prepare, lead and drive risks review meetings (RRM) by ensuring meeting dynamic and performance, bringing all relevant facts & data to make appropriate decisions if needed and engaging before and after on mitigation execution.

• Ensure the appropriate escalation of risks to the appropriate level (RRM, RMCB)

• Is able to sit next to a risk owner or at the MPU Leadership team table and have him/herself heard because (s)he is:

• Previous experience in multidisciplinary activities in highly scientific environment with GMP rules (business acumen)
• Recognised for building true partnership with stakeholders

• Compliance :

• PQTS :

• Implement and maintain an organizational structure to ensure the realization of the monthly and biannual PQTS meeting by meetings planification, definition of standard analyses time, follow-up with KPI, write minutes of meeting and share to the community, …)

• Coaching on the risk analysis linked to the TS activities.
• Understand and bring support for technical / production complex problem and evaluate potential risks or impacts.

• QMS :

• Implement and maintain the quality managing system in the MPU.
• Act as LSPOC of the QMS quality system by managing the applicability document in the MPU, bring information to perform gap analysis, review gap analysis and follow-up.
• Act as SME by performing gap analysis related to the area of expertise.
• Bring support to the SME for the realization of gaps analysis.
• Reporting to the MPU leadership team and QMS champion.

• Pest control :

• Act as LPSOC pest control by ensuring the pest control protection of the MPU buildings.
• Manage risk assessment pest control in collaboration with the SME pest control
• Analyze the trend report and take corrective/preventive action.

• Complaint :

• Act as complaint investigator owner by performing investigation of the complaint, identifying potential root-cause, the need to escalation and the appropriate remedial actions if applicable.
• Perform complaint analysis related to the deviation initiated linked to out-of-control batches of GSK.

• Additional Key responsibilities:

• Management of employee’s team, distributes their work and is responsible for their training and development plan
• Perform internal audit L1 and is fronter for internal audit L2 in his department related to the area of expertise.
• Manage deviation investigation, assess a potential impact product, define the root-cause and identify corrective and preventive action.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• University degree in Sciences

• Fluency in French and English is a must: written and spoken

Preferred Qualifications:

If you have the following characteristics it would be a plus:

• Min. 5 years’ experience in the pharmaceutical industry, in a cGMP environment.

• Experience in a pharmaceutical production is an asset

• Coping with various environments,

• Having strong relationship skills

• Being capable to understand quality system

• Communication and organizational skills

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

• Li-GSK

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.