Quality Systems Manager to Bio-Works

Bio-Works is looking to further strengthen our strategic position in Life Science by adding a Quality Systems Manager to the team. We need your help to create and monitor quality processes to ensure that instruments, systems, processes and people produce products and services in accordance with company, industry/customers and ISO:9001:2015 requirements.

ABOUT THE ROLE 🔎
In this role, you will drive improvement work for developing the quality strategy, policies, processes, standards and systems for the company in close collaboration with the Director of Quality, the Quality team (QA & QC) and cross-functionally with the whole organization to achieve Quality Management System (QMS) targets for customer and business goals. Embed a culture of continuous improvement throughout the company and hold quality related trainings to support this within the company.

You will;

- Support the implementation, configuration, and management of new electronic QMS software including document organization, migration and training. Being a super user for the system.
- Support daily operations of internal quality system including the full document lifecycle for Nonconformity Reports (NCs), Corrective Actions/Preventative Actions (CAPAs), Change Control (CC), Management of Change (MoC) and release as applicable.
- Identify and address opportunities for efficiency improvement as well as having overview/support that the in-house systems and procedures are updated, revised and clear to meet the need of internal and external parties, including certification bodies and customers.
- Introduce new systems and procedures where appropriate in the QMS.
- Conduct risk assessments of processes and tasks within the quality area for the organization.
- Be our quality validation/qualification lead including to support and develop a robust approach for statistical techniques to determine sample sizes for different types of products / testing.
- Monitor and report on relevant quality KPIs and metrics to assess the effectiveness of the QMS, in for example Management review.
- Support creation and implementation of best practice capacity planning within QA/QC and cross-functionally to aid and improve operational performance.
- Support cross-functional projects, meetings and activities as core team quality representative, as necessary.
- Contribute to new business initiatives and projects and review and communicate the impact on the Quality Management System
- Be our internal and external auditor as applicable together with the Quality team and support in supplier management including quality agreement review and approvals.
- Train, coach, motivate and develop others in all aspects of the quality system and application of procedures to add value as well as continuous improvements and quality culture.
- Provide quality expertise for the QA/QC teams specifically.


The Quality team (QA/QC) consists of you, QA Manager, QC Lead, QC Specialist and our Director of Quality.

DESIRED BACKGROUND 👩🏾‍🎓👨🏻‍🎓

- Minimum of a bachelor’s degree in a life sciences, healthcare or technology discipline
- Minimum 5 years in a regulated environment such as for example pharma and/or medical device company, in a QA/QMS role
- Experience managing and/or working with ISO:9001 standard (or other related and suitable ISO standards)
- Experience within QMS systems for 3+ years
- Experience investigating, writing, and reviewing/approving non-conformance reports, CAPA, and Change Control errands
- Strong planning and communication skills
- Experience with cross-functional, multicultural, and international teams, preferably as a team lead, project lead etc
- Business fluency in English and Swedish
- Previous experience of training others is meritorious
- Statistical knowledge is highly meritorious
- Audit experience is desired


To be successful in this role you need to have a proactive attitude focused on identifying problems and finding solutions and demonstrate a high degree of personal credibility and integrity. You also need a precise and analytic mindset that recognizes and focuses on issues and risks as well as high sense of ownership and accountability. And last but not least, you need to have a bridge-building perspective while balancing the interests of internal and external stakeholders.

WHAT DO WE OFFER? ✨
In addition to a fun role, you are offered the opportunity to enter an exciting company in growth with great and incredibly competent colleagues. We offer you flexibility in the role and you have the opportunity to work from home as needed and adjust your working hours so that your life at home also flows smoothly. We have breakfast on Mondays, fika on Fridays and are also good at doing other things together - such as fitness activities, lunches and afterwork.

We of course also have good benefits such as 30 days of vacation per year, ATF-hours (shortening of work hours) which we spread out over the year for some extra time off, wellness benefits, occupational pension, insurances and more.

GOOD TO KNOW 💡
Start: According to agreement
Form of employment: Permanent employment (6-month probation)
Scope: Full-time 40h/week (100%)
Location: Uppsala (Uppsala Business Park)
Bio-Works has a collective agreement according to IKEM.

APPLICATION 📤
Last application date is 2022-10-30. We do not accept applications via e-mail. We will process applications continuously so please apply as soon as possible. The position requires you to be a citizen in the EU/EEA/Switzerland region or to have the authority to work in Sweden.

ABOUT BIO-WORKS 🧪
Bio-Works enables scientists to achieve their purification goals, from laboratory research to large scale bioprocess production. Our vision is a biotech industry that embraces, develops and builds on new methods and novel ideas. WorkBeads™, Bio-Works’ next-generation, agarose-based products, are used to purify proteins, peptides and other biomolecules, resulting in purer therapies and safer diagnostics. Through collaboration with customers and partners, we develop purification solutions that make important medicines available and accessible to everyone.