DIRECTOR, QUALITY & RA
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.
As Director, Quality & Regulatory Affairs, you will head up the entire QA-, QC- and Regulatory areas. Covering more than 25 employees, the role enables you to use your leadership competencies on a site in rapid growth.
You will become a part of the site management team and will be responsible for ensuring the fulfilment of the QA & RA strategies and their execution. A key task of the role will be to take leadership of the team, ensure alignment with key stakeholders and create an engaging work atmosphere. Furthermore, you will be a key player working directly and indirectly with a wide variety of contacts, both internal and external, including business partners, customers and authorities, which requires a high level of impact to ensure the right course of action is taken in a variety of areas, while defining and promoting a quality mindset across the company.
The role offers an excellent opportunity to take the leadership of the Quality & Regulatory Affairs organization while being a professional coach and sparring partner for the team. Leadership, business acumen, compliance and employee engagement are key elements to succeeding as Director, Quality & Regulatory Affairs.
Director, Quality & RA
Global Director Quality & Regulatory Affaires
20-30 days per year
Responsibilities & Tasks:
Leading the QA/RA function (Quality Assurance, Regulatory Affairs, Quality Control and Environmental Monitoring) consisting of 25+ employees and develop an optimal organizational structure to support the business.
Executing initiatives to continuously improve quality awareness and processes in line with applicable regulations and guidelines for the industry and have the overall responsibility for site GMP credentials and license to operate (§39 & GMP certificate for sterile API).
Serving as an active member of the site Management Team and the Health Care Quality & Regulatory Management Team, and develop and set the Quality & Regulatory strategy and goals for the site
Hosting inspections and audits from health authorities and customers and ensure timely resolution of compliance issues
Scheduling and execute the internal and the supplier audit program
Being responsible for maintenance of the sites submitted Drug Master Files and maintain an effective regulatory intelligence applicable for the site’s activities.
Defining and measuring the sites Quality Performance by quality metrics, and be the owner and host of the sites Quality Management Reviews process as well as the represent of the site in the global Health Care QA/RA Management team
Leading, developing and coaching employees to build a highly capable team
Developing and maintaining positive relations with a wide variety of contacts, both internal and external, including business partners, customer and authorities.
Executing the business strategy. Hereunder take part in developing the business strategies and prepare plans for the implementation of strategic initiatives.
Navigating and collaborating with many different cultures and professional backgrounds.
Key success criteria:
Developing an inspirational and high-performance culture in Quality & RA.
Ensuring strong team engagement.
Successfully leading the Q and RA functions to meet overall company and quality goals and ensure performance of Q & RA Metrix.
Striking an optimal balance between compliance and business needs.
Driving to good collaboration with internal and external stakeholders.
Preferably M.Sc.-degree within Pharma or Nature Sciences
Danish and English – fluent (verbally and written)
Ideal experience and competencies:
10 year+ experience from pharma, preferable aseptic manufacturing
Experience with adjuvants/vaccines is a plus
Well established expertise in GxP and global regulations
Demonstrated leadership 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.
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.