An exciting opportunity is available for an experienced manager to join a rapidly growing global probiotic company based in Sweden as our Regulatory Affairs and Quality Assurance (RA/QA) Director. The position can be based either in Stockholm or Lund.
Define appropriate global regulatory strategies and develop clear and simplified procedures to secure successful product registration, commercialization and lifecycle management as well as contribute to the sustainability of the business. The ideal candidate will be a strategist with the capability to be immersed in the day-to-day regulatory and quality assurance operations to support the team. The individual shall lead RA and QA teams and be a member of the Operations Leadership team reporting to VP Operations.
- Collaborate with relevant regulatory bodies to influence and promote appropriate legislation for probiotic products.
- Propose, develop and implement strategic direction for product portfolio in collaboration with Business Units.
- Support development of new products through creative regulatory plans and appropriate documentation, securing first-to-market principle.
- Define appropriate quality requirements and simplified quality system to ensure compliance with relevant legislation as well as a competitive approach within relevant product segment through a risk-based approach.
- Develop efficient internal regulatory procedures and ways of working to support global product launch and commercialization.
- Further develop existing quality management system for internal use and supplier compliance in line with relevant legislations and guidelines.
- Closely collaborate with Supply Chain department in order to deal with suppliers and monitor CMOs
- Maintain current regulatory and QA knowledge within defined and relevant areas.
- Lead Quality Assurance and Regulatory team members, including performance planning, staff development, coaching & training, ensuring that operational plans and resources are in-place to deliver objectives.
- Establish and maintain a network of experts and consultants world-wide to support business growth in line with defined company strategy.
Education and experience:
- M Sc degree in microbiology, biotechnology, biomedicine or a related field.
- At least 10 years of experience from regulatory affairs in pharmaceutical, food supplement, probiotic, food industry, medical device and/or health authority from global environment with a commercial focus.
- At least 5 years of experience in line management, involving organizational matters, decision-making and team development.
- Scientific knowledge sufficient to understand all aspects of regulatory issues.
- Thorough knowledge of cGMP and/or ISO 22000 compliance and regulations.
- Experienced in RA/QA operational activities such as creating regulatory and launch strategies, regulatory submissions, life cycle management from a global or regional perspective, identify and mitigate regulatory risks, quality standards and quality management systems, etc.
- Proven ability to think strategically and interact with senior management.
- Experienced in making decisions through a risk-based approach.
- Proven ability to manage multiple and competing priorities through effective organizational, people and time management skills.
- Certification in regulatory affairs is an advantage.
- Fluency in Swedish and English. Other language skills are an asset.
Skills and personality:
- Excellent organization and communication skills, including experience dealing with decision makers, such as distribution partners, regulatory bodies and policy makers.
- A ‘can-do’ attitude.
- Driven by curiosity identifying creative solutions.
- Strong wish to join a small company to work in a fast-paced environment.
- Ability and willingness to travel.
As the Director of Analytical Development (AD) you will have an overall responsibility for all analytical development activities, including method development, characterization of culture powders and stability studies of cultures and finished products, to support development as well as life cycle management.
You will also be Site Manager for BioGaia Centre of Excellence in Eslöv. In this role you will be responsible to implement a functional multidisciplinary research laboratory including overall safety, health and environment aspects, quality system and responsibility of cleaning and purchase of consumables. The Site Manager role will count for approximately 10-20 % of your working time.
Responsibilities include but are not limited to:
- Lead the team, establishing and communicating strategic direction, providing business context, coaching and direction to enable the team to meet its performance targets.
- Lead team members, including performance planning, staff development, coaching & training, ensuring that operational plans and resources are in-place to deliver objectives.
- Accountable for matters such as maintaining quality, accuracy and quantity of work; providing advice, guidance and direction; dealing with routine problems; and developing detailed internal work methods.
- Responsible for establishing and deploying analytical expertise infrastructure, and operational systems and methods.
- Evaluate, develop and implement new technology to increase both efficiency and scientific level of the lab. Note: not limited to microbiological methods.
- Life cycle management of culture powder and commercial products.
- Ensure that appointed team members act as fully functional members of cross-functional teams to provide expertise and support with regard to the analytical methods and stability studies.
- Provide analytical support for culture and product development, manufacturing process design, optimization, validation, transfer, and commercialization as needed.
- Define, develop, implement and maintain appropriate standard for the operating activities in compliance with defined quality requirements ensuring efficiency. Ensure compliance to the defined quality system.
- Provide strategic direction for outsourcing analytical development and methods to another laboratory wherever required.
- Development, validation/verification and transfer of analytical methods.
- Characterization of culture powders in development and commercial phases.
You are based at our Centre of Excellence in Eslöv and your organization consists of 9 people (senior laboratory engineer, laboratory engineers, senior analytical scientists, laboratory technicians and site support). You are a member of the Operations management team and you report to VP Operations, based in Stockholm.
- M.Sc. and/or PhD degree in biotechnology, analytical chemistry or a related field.
- At least 10 years industrial experience from analytical department (AD and/or QC), product development, project management and w1orking in a matrix organisation.
- Thorough know-how of cGMP/GLP and/or ISO 17025 compliance and regulations
- Experienced in AD/QC operational activities such as sampling and sample reception and registration, product specifications, stability programs etc.
- Experienced in leadership involving organizational matters and decision-making.
- Experience of line managing team with a wide range of roles and responsibilities.
- Strong interpersonal, organizational and workload planning skills
- Ability to think strategically and interact with senior management.
- Ability to manage multiple and competing priorities through effective organizational, people and time management skills.
- Excellent written and verbal communication skills in Swedish and English.
Your personal features:
Very important are your personal features. In order to fit in and be able to be successful in the role, we believe you need to be/have:
• a coaching and supportive leadership
• solution oriented and be able to think out-of-the-box
• a clear communicator
• strategic and at the same time be able to take detail discussions
• be comfortable in not always understanding all the details and still be able to support your
employees in specific areas
• strong ethical values with high integrity
How to apply
In this recruitment BioGaia is partnering with Academic Search International. If you have any questions regarding the process or the position, please contact Senior Consultant Mats Nordin at 0707-516740 or firstname.lastname@example.org or researcher Maja Frick at 0737-462143 or email@example.com. Due to summer vacation we kindly ask you to email your questions during the weeks 29-32 and we will get back to you as soon as possible.
Please apply to the position by clicking the link below and attaching your CV + cover letter. We look forward to your application as soon as possible, however no later than August 30th, 2019.
Arbeta på ett av Sveriges mest jämställda företag
Vi ser goda relationer till medarbetarna som en framgångsfaktor. Under snart 30 år har vi byggt vårt varumärke på tilliten till medarbetarnas kompetens, deras personliga engagemang och vilja till utveckling. Det är medarbetarna som har skapat dagens BioGaia. Läs mer
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