Computerized Systems (CS) Manager

Computerized Systems (CS) Manager

Basildon, Essex: hybrid role (3 days office/2 days home)

Full-time, permanent position

Salary: Competitive + Benefits + Bonus

If you are an experienced, enthusiastic, and agile CS Manager within the pharmaceutical quality environment, then we want to hear from you!

Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As CS Manager, you will be responsible for the creation, implementation and oversight of CS compliance, validation, and life cycle maintenance processes, to enable deployment and maintenance of compliant CS. A key deliverable of the role will be to ensure that the GxP computerized systems meets the regulatory (GMP Annex 11) and operational needs of Pharmanovia.

Reporting directly to the Senior QA Manager, you will be part of the Quality Assurance Department with its ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities and duties:

• Primary interface to all internal customers to CS compliance
• Managing internal and external audit activities, including clients, as the Pharmanovia CS SME
• Managing and reviewing the documentation of new or existing CS updates
• Assisting with the development of effective remediation plans for CS deficiencies
• Reviewing of CS implementation plans (both new systems and upgrades) to ensure compliance with internal processes, change control assessor
• Input, communicate and evaluate risks associated with CS
• Document owner for the Pharmanovia Site Validation Masterfile
• Ensuring that individual tasks related to the implementation of the GxP computerized systems are completed within the desired timeframes to an exceptional standard
• Effective management of all the CS related activities, including setting and monitoring key performance indicators (KPIs) and presenting these KPIs at the Quality review meeting
• Undertaking customer and supplier onboarding due diligence checks

What we are looking for:

Candidates with at least 3 years' proven experience in CS implementation management within pharmaceutical quality are likely to have the skills and knowledge required to be successful in this role.

We are also looking for:

• Bachelor's degree in Computer Science, Information Systems or equivalent
• Clear understanding and working knowledge of GMP, Annex 11, GAMP and MHRA Data integrity regulatory requirements and guidelines
• Experience of facilitating investigation and root cause analysis, CAPA and change control processes
• Experience of routinely preparing, reviewing and approving validation documentation and SOPs
• Experience of CS supplier auditing
• Thorough knowledge of quality systems of pharmaceutical companies
• Ability to explain technical concepts to non-technical personnel
• Good organisational and time management skills, with a logical and methodical approach to work
• Ability to cooperate and build strong working relationships both internally and externally
• Flexibility, positive attitude and willingness to assist
• Ability to work independently and with multiple levels within the organisation
• Excellent communication skills both written and oral

In return:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.