BRIEF COMPANY PROFILE
Our client is one of the biggest producers of immunological and vaccine additives in the world.
The company operates under Pharma GMP and exports to customers across all continents.
The company's products are incorporated in more than 2 billion vaccine doses yearly and contributes to making vaccines effective against cervical cancer, polio, hepatitis, tetanus, diphteria, whooping cough, botulism and anthrax.
The worldwide use of our client´s product requires an organization capable of producing in a responsible manner according to global quality standards. In order to live up to these standards and continually excel at contributing to the increased efficacy of vaccines, the organization comprise a highly specialized team with extensive knowledge of the optimal usage of different additive solutions in vaccines and the production of these according to current best-practice manufacturing standards.
The QC Manager will lead the Quality Control function at our client´s site, on a continued journey of expanding activities as well as developing GMP compliance in line with the company’s long-term plans.
Heading up a substantial team, the role will be responsible for 6 Chemists, 9 Technicians and 1 Environmental Specialist, working in close collaboration with mainly supply-, support- and QA functions. Besides the day-to-day operations, QC has an active project portfolio supporting the short- and long-term development of the function as well as the total site.
The role offers an excellent opportunity to take the leadership of the QC team while being a professional coach and sparring partner for the team on operational matters. Management, structure, compliance and employee motivation are key elements to succeeding as QC Manager, Quality & Regulatory Affairs.
Director Quality & Regulatory Affaires
Responsibilities & Tasks:
Defining strategy, goals and priorities for the QC function.
Monitoring general performance and performance of QC Quality Metrix.
Ensuring raw materials, intermediates and finished products are analyzed according to approved specifications.
Ensuring the QC function work according to defined SOP’s, applicable laws and GMP regulations, and that applicable authorizations are maintained (including for euphoria substances).
Assuring any deviation from approved SOPs are handled in a deviation.
Providing leadership to the QC team, hereunder initiating team building activities, training and development of team members.
Expanding the appropriate competences and quality awareness within the QC function.
Maintaining product stability program.
Ensuring QC equipment is qualified and QC methodsare validated.
Responsible for the QC budget within approvedscope – hereunder budget planning and follow up.
Continuously improving processes and activitieswithin the QC function.
Ensuring external analysis is conducted at approvedcontractors.
Overseeing QC tasks and projects.
Overseeing safety rules are implemented and followed in the QC function – hereunder acting as Safety Representative for the QC function.
Hosting internal audits in QC.
Ensuring clear roles within the QC team on auditsfrom customers and authority inspections.
Assigning QC team roles in audits of contractlaboratories.
Key success criteria:
Contributing to developing an inspirational and high- performance culture in QC.
Ensuring strong team engagement.
Successfully leading the QC function to meet overallcompany and quality goals and ensure performanceof QC Quality Metrix.
Develop an efficient, structured and GMP compliantQC operation.
Contribute to good collaboration with internal andexternal stakeholders.
Preferably M.Sc.-degree within Nature Sciences preferably with a microbiology minor/major.
Danish and English – fluent (verbally and written).
Ideal experience and competencies:
Preferably 10+ years of experience with GMP in the pharmaceutical industry.
4-5+ years of experience with Quality Control preferably in an aseptic GMP manufacturing environment.
Proven leadership experience as well as strong communication and personnel management skills.
In-depth knowledge of GMP/cGMP regulations.
Solid experience with handling of deviations/NCR’s,change control, risk evaluation, SOP development/updating.
Experience with driving change, optimization projectsand preferably LEAN experience.
Quality-minded with a business focus
Is concerned with reaching and maintaining quality; sets high standards for performance and execution – for one self and for others. Balances quality and business.
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through. Can manage multiple projects and teams simultaneously.
Is proactive and exercises good judgment in selecting innovative, practical methods to achieve problem resolution. Is able to multitask and inspire others; is able to take own initiatives without hesitation. Actively seeks influence and starts up actions on own initiative.
Delegates responsibility to the relevant employees and allows them room for manoeuvre to explore own initiatives, empowers people in order for them to carry out tasks efficiently.
Likes to stay busy while assessing the importance of considerations, decisions and actions, analyses the most important issues first. Focuses on deadlines.
Communicates the central issues in a discussion in a clear, fluent and precise manner, is able to keep the recipients' attention, attentive to the needs of others when he/she speaks. Produces written material, which is clear, fluent, precise and easy to understand for the recipients.
Identifies issues and take appropriate actions according to corporate guidelines and policies.
Works systematically; organizes work and effort; is methodical in one's performance; holds on to commenced tasks and projects.
‘Can do’ team attitude. Collaborates; works well with others with a view to obtain the team's objectives; shares information; supports others.
For further information:
Please contact Henrik Brabrand, CEO, Albright Partners A/S at:
M: +45 7199 2799