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Senior Manager, QC

Greater Copenhagen, Denmark
BRIEF COMPANY PROFILE
Our client
Our client is one of the biggest producers of immunological and vaccine adjuvants in the world.

The company operates under Pharma GMP and exports to customers across all continents. Adjuvanters 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 GMP manufacturing site is located in Denmark and in recent years, our client has made substantial investments in the manufacturing plant in Denmark with the objective of expanding production capacity. Additionally, continuous and costly upgrades have been prioritized to ensure continuous GMP compliance.

Our client’s adjuvants are used in vaccines across the entire world. This requires an organization capable of producing adjuvants 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, our client’s organization comprise a highly specialized team with extensive knowledge of the optimal usage of different adjuvant solutions in vaccines and the production of these according to current best-practice manufacturing standards.
 
THE POSITION
The Senior Manager, QA will lead the Quality Control function 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 and 9 Technicians 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 in Denmark.

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 Senior Manager, QA.
 
POSITION PROFILE
Position title:
 
Senior Manager, QA.
   
Reporting line:
 
Director, Quality & Regulatory Affairs.
   
Reporting to the position: 15 direct reports (6 Chemists and 9 Technicians).
 
   
Location: Denmark.
   
Traveling: Limited
   
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 methods are validated.
  • Responsible for the QC budget within approved scope – hereunder budget planning and follow up.
  • Continuously improving processes and activities within the QC function.
  • Ensuring external analysis is conducted at approved contractors.
  • 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 audits from customers and authority inspections.
  • Assigning QC team roles in audits of contract laboratories.
   
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 overall company and quality goals and ensure performance of QC Quality Metrix.
  • Develop an efficient, structured and GMP compliant QC operation.
  • Contribute to good collaboration with internal and external stakeholders.
 
CANDIDATE PROFILE
Educational background: Preferably M.Sc.-degree within Nature Sciences.  Preferably with a microbiology minor/major.
   
Language: Danish and English – fluent verbally and in writing.
   
Ideal experience:
  • 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 projects and preferably LEAN experience.
   
Personal & leadership competencies: 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.

Leadership
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.

Good judgment
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.

Delegation

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.

Prioritizing

Likes to stay busy while assessing the importance of considerations, decisions and actions, analyses the most important issues first. Focuses on deadlines.

Communication
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.

Compliance
Identifies issues and take appropriate actions according to corporate guidelines and policies.

Structure
Works systematically; organizes work and effort; is methodical in one's performance; holds on to commenced tasks and projects.

Team orientation
‘Can do’ team attitude. Collaborates; works well with others with a view to obtain the team's objectives; shares information; supports others.

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