QC Manager Documentation and Archive

¾ You’ at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise 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 In this role you will… QC manager Documentation and Archive Develop and maintain high standards of skills and capabilities within the QC to meet business objectives and drive performance. Ensure Documentation and Archiving management processes and systems are in place, in use, and maintained at the appropriate level to ensure business continuity Ensure Documentation and Archiving management processes and systems are in compliance with cGMP standards, Heath Authorities expectations, as well as GSK standards Define Documentation and Archiving needs with the N+1: regularly assesses documentation and archiving plans to identify common requirements, make sure Documentation and Archiving process or system gaps are managed end to end with continuous improvement in mind; (ea. document architecture changes, training approach changes, training matrix update); issue/risk related to Documentation and Archiving readily identified, corrective/preventive actions established, implemented Ensure adequate Key Performance Indicators and processes (i.e. tier meeting, …) are in place and in use in all the QC department to monitor, track, and drive progress Assure uniformity/best practice implementation of Documentation and Archiving management processes and systems across QC. Evaluate the applicability and the impacts in case of proposed changes of the SOPs/WKI of this process Be the first local trainer for QC for this process Train and coach authors, reviewers and approvers of Documentation ‘type SOP’ in respect with the best practices embedding in the current Doc & Training process. Contribute to the QC vision and mission, drive execution across functions and steers projects based on Business Documentation & Archiving needs and Enterprise –wide programs. Actively contribute to the global Documentation & Archive management community with the intent to further align and improve the overall documentation strategy within GSK in partnership with the Global Documentation organization. Effectively present the Documentation & Archive management processes and systems during Health Authority inspections Be the local operational expert of the Quality processes (Documentation & archiving and QMS) Perform audit L1 and EHS audit As a line Manager: Effectively develop and coach his/her team, responsible for his team daily work management, allocation of tasks, daily reporting. EHS: We expect that you: Understand, assess & manage all risks related to the activities of your team. Ensure suitable & sufficient preventive measures are implemented, and your employees have necessary skills and medical aptitudes. Give to your team the necessary means to manage all aspects related to PTW, LOTO process and Risk analysis procedure. Dedicate quickly sufficient resources to ensure that incident investigation to identify root cause, CAPAs implementation & CAPAs transversal sharing is performed as soon as possible. Complete adequate monitoring on the shopfloor focusing on risk management. Provide EHS advice and promote continuous EHS improvement. Promote reporting of any unsafe conditions and behaviors through reporting system (HazId). You take immediate action where possible to rectify the situation. Why you? Qualifications & Skills: Master’s degree in a scientific discipline with min 5 to 10 years of relevant experience Good understanding and knowledge of regulatory guidance and cGMP/GQP/GQMP requirements Preferred experience in Documentation and Archive Good knowledge in English and fluent in French Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style Well-developed relation building skills to gain trust and credibility and to build a great place to work and good social climate within cross functional teams Excellent team builder / team player Customer oriented: ability to active listening to internal customers and pro-actively proposing solutions based on their needs Effective communication skills (communication with different stakeholder), including training / animation / presentation skills Effective influencing skills – ability to influence at all levels of management and to energize a team towards to pursue common goals Strong quality and results oriented mindset Maintain a high level of integrity while balancing multiple priorities and responsibilities Ability to lead and drive change Preferred Qualifications & Skills: Able to interact with scientist and managers. Able to turn theoretical learning into practical tools. 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?: 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. 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. 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. 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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.