Computer System Validation (e-Compliance) Manager
Elvie are looking for a Computer System Validation (e-Compliance) Manager to join their team.
Life at Elvie - Meaningful work. Exceptional people
At Elvie, we don’t believe women's bodies are the problem. Instead, we believe the problem is that the needs of women’s bodies – and therefore, lives – have been ignored, misunderstood, and underestimated.
Founded by Tania Bolder in 2013, Elvie has been improving women's lives through better – and smarter – technology ever since. We develop innovations that meet the unique needs and complexities of the female body so that women can take charge of their health across every life stage.
Our first product, Elvie Trainer, is a multi-award-winning device bringing hospital-grade pelvic floor care to the hands of women everywhere— it was even a gift in the Oscar Nominee Goody Bags! And now, we're proud to say that we're part of the NHS Supply Chain in the UK.
Our second innovation was Elvie Pump. Launched in 2019, it's the world's first silent, wearable breast pump, enabling women to pump wherever they please— even the catwalk at London Fashion Week. It’s since won numerous awards, including the Times 100 Best Inventions of 2019 and ‘Wearable Design of the Year’ at the Dezeen Awards. The initial success of our wellness tools gave us the means to expand our breastfeeding range to include Elvie Curve and Elvie Catch, both designed to give mothers total comfort and confidence.
As a business, Elvie has received more than 30 awards (including the prestigious Red Dot Design award). We’re ranked as one of the 15 startups ‘To Watch’ by The Sunday Times and Business Insider and ranked as the 13th fastest growing business in the UK by Syndicate Room. Our founder and CEO, Tania Boler, is regularly profiled in top-tier media titles, and, in 2021, Tania was named GLAMOUR’s Women of the Year: Technology Gamechanger.
In July 2021, Elvie announced an $80 million Series C funding, the number one position and biggest raise in an initial fundraising round in the femtech category.
What does it mean to work at Elvie?
You will be surrounded by people who want to improve everything and everyone around them. People who are passionate about our mission. People who are driven to solve tough problems and constantly consider the best ways to improve the health and wellbeing of women.
We're deeply proud of our values, which are intrinsic to the way we behave every day. We take them seriously because we want our culture to thrive:
- We make an impact - we are mission driven and not afraid to break boundaries. We relentlessly focus on going the extra mile to solve problems
- We are fearless innovators - we are passionate, curious and data-driven. We continuously embrace change and innovation
- We are in it together - we fail and learn fast, always as one team, and have fun along the way. We stay authentic and embrace our differences
About the role
The Computer System Validation (e-Compliance) Manager shall provide lifecycle support to the deployment of all GxP software. The Computer System Validation (e-Compliance) Manager shall assist the Lead Quality Systems Manager in support of the upgrade and implementation of the Quality Management System (QMS) where it impacts GxP systems to assure it is aligned with regulatory expectation.
What you’ll be doing
- Responsible for writing Policies and Procedures regarding IT computerised systems and ensure adherence to these and other related policies.
- Responsible for the assessment of software systems used at Elvie to determine appropriate validation requirements to meet global GxP regulatory requirements.
- Lead computer system validation efforts related to authoring and executing specifications and validation documentation for computer systems, in alignment with Good Manufacturing Practices (GMPs) and ensure adherence to these.
- Reviews computer system validation documentation, to ensure data integrity requirements are maintained.
- Participate in change control processes to ensure changes to processes, products, systems and facilities are appropriately assessed and implemented. Assess impact on systems when change requests are submitted and participate in change management, where required.
- Participate in activities/projects as Quality IT subject matter expert and provide compliance support and guidance. Lead continuous improvements where required.
- Support the review of potential software suppliers for their suitability to supply computer software and equipment to GMP/GAMP standards.
- Identify compliance risks (with respect to industry regulations impacting computer systems) and proactively work with departments to address.
- Ensure the implementation and lifecycle management of IT systems meet manufacturing regulatory guidelines such as Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practices (GAMP).
- Influence and enforce Good Documentation Practice standards.
- Supervise any CSV Engineers and/or contractors. Develop the team and promote business succession planning.
- Develop and implement an ongoing education process for CSV processes. Create training records for training events held.
- Provide process leadership, drive quality initiatives and support the continual improvement of Quality System processes and tools that support the product lifecycle. Provide support to the Quality Systems Manager.
- Support internal audits and external audits, where required, utilising prior experience and qualifications, directing the response and resolution to any feedback, communicating observations and addressing any systemic issues.
- Computer science or IT degree or a minimum of 3–5 years relevant experience in validation of control/ computer systems within medical device or pharmaceutical industry.
- Candidates must be familiar with GAMP 5 and CFR21 Part 11, EU Annex 11&15 and Data Integrity requirements.
- Solid experience within an IT compliance or computer system validation role within a regulated industry, preferably medical device or pharmaceutical. Knowledge of software development lifecycle. Knowledge of agile and waterfall methodologies.
- Experience writing validation/qualification documentation within a regulated environment.
- Comprehensive appreciation of Medical Device Quality System.
- Must be familiar with commonly used software such as Microsoft Office and Google suite. Preferable to have experience using an Electronic Quality Management System.
- Self-starter capable of working independently and following a best practice approach.
- Able to work effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships.
Elvie is at the crest of a wave! Founded by women's health expert Tania Boler and tech entrepreneur Alex Asseily, Elvie is a collection of bright and motivated team members working across the business to shape the emerging femtech industry.
We are passionate about creating disruptive products that address the challenges that matter most to women and dismantling the taboos around women’s bodies. Here, you can be part of a business and brand that has a positive and meaningful impact on the world, while learning a great deal and having fun.
What are some of the perks of working at Elvie?
We are looking after you. As well as the chance to develop products with real work impact and working with dedicated and passionate colleagues, our benefits have flexibility and wellbeing in mind with
- Flexible work environment built on trust and autonomy
- Employee / friends & family discounts on Elvie products
- Annual personal development allowance & unlimited access to our learning & development platform
- A tax-efficient group pension scheme with SmartPension
- A tax-efficient charity donation scheme
- Life Insurance with Yulife
- Medical, Dental & Optical cash-plan
- Employee Assistance Program for you and your family
- Generous employee referral program
- Cycle Scheme & Tech Scheme
- YuLife Well-being app & access to SmartHealth app with unlimited GP appointments for you and your family, plus various well-being initiatives throughout the year
At Elvie, we believe in having diverse teams in which everyone can be their authentic self is key to our success. We encourage people from underrepresented backgrounds to apply and we don't discriminate based on race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, marital status, disability or age. We are a family-friendly employer with a culture based on trust, autonomy and flexibility, and are working on making our offices wheelchair friendly and breastfeeding friendly. We do our best to accommodate part-time requests and flexible requests as much as possible. We are also a member of UK Tech Talent Charter and proudly working in partnership with myGwork and Women's tech hub.