Site conformance Manager (Permanent Contract)

Job purpose:

The Site Conformance department is part of the QA Release team and support it regarding the requirement of the European cGMPs (Eudralex vol4). Eudralex define that the purpose of controlling batch release is to ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorization.

The principal duty of the Site Conformance Manager is :

1. To ensure as quality representative, compliance to regulatory dossier of activities related to Manufacturing Performance Units or Quality Control Department

2. To ensure the regulatory oversight within Manufacturing Performance Units or Quality Control Department.

By ensuring this duty, Site conformance contributes to avoid supply issue, delay or recall due to misalignment to file.

Your responsibilities:

• You provide Chemistry/Manufacturing/Controls (CMC) and regulatory expertise within Manufacturing Performance Units or Quality Control Department, to ensure continuous alignment of Operations with the approved data by Health Authorities.

• You support Manufacturing Performance Units or Quality Control Department for CMC processes

  • Responsible of quality oversight of source documents and ensure providing the operational documents to support GRA in authoring post approval changes’ variations

  • Approve, on behalf of Operations, submitted documents to Health Authorities in the frame of Regulatory Submission Process.

  • Lead Questions & Answers and Commitments process within Manufacturing Performance Units or Quality Control Department.

  • Support QA and MPU head in the prioritization of the CMC subjects in their area

• You oversee Change Control

  • Being responsible for decision making of Regulatory impact of changes (initial assessment of the potential regulatory impact of changes).

  • To support Global Regulatory Affairs in defining regulatory strategy on behalf of operations

  • To support Operations in defining implementation and release strategy with regards to Regulatory matters.

• You support MPU/QC head and QA head by being the Single Point of Contact (SPOC) for any decision related to regulatory compliance.

• You are responsible for coaching and developing regulatory awareness of Manufacturing Performance Units or Quality Control Department.

• You are responsible for coaching and developing awareness of MPU/SPU shop floor practices to GRA team.

• You provide technical support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities in the frame of post approval changes management.

• You provide CMC and regulatory conformance expertise to support release of products in compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.

• You are empowered to take decision in grey area for regulatory topics.

Why you?

Basic Qualifications:

We are looking for professionals with the following required skills to achieve our goals (must-have):

• Minimum 7 years in Pharmaceutical Industry (preferably in an FDA approved context) including minimum 5 years in Regulatory

• GMP knowledge

• Technical understanding of product manufacturing processes and/or testing

• good knowledge in English

• Sense of urgency, flexibility and accountability Enterprise thinking (cross functional team spirit, sharing of good practices within the network)

• Strong quality and results oriented mindset

• creative approach to problem solving and the ability to challenge the status quo

• Ability to work across boundaries

• Customer oriented: ability to active listening to internal customers and pro-actively proposing solutions based on their needs

• Effective communication and coaching skills

• Effective leading and influencing skills – ability to influence at all levels of management and to energize a team towards to pursue common goals

• Excellent team builder / team player

• Flexible thinking and ability to support/drive changes

• Assertive

• Lean culture spirit

Preferred Qualifications:

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

• Demonstrated ability to quickly understand end to end process

• Demonstrated ability to take full accountability of small or medium project

• Good analytical and problem-solving skills

• Li-GSK

GSKTechTalent

Why GSK?

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.

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.

Our department:

Vaccines Global Qualityis responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

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.

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.