Ref

7891

Title

SENIOR QA/QC MANAGER - EMEA

Sector

Pharmaceutical

Salary

£60K - £70K + Bonus + Benefits

Location

 Kent

The Company

Colorcon, headquartered at Harleysville, Pennsylvania in the USA, is an innovative, progressive and highly successful global business and a world leader in its field. It is an operating subsidiary within the long established and family owned Berwind Corporation, an investment management company headquartered in Philadelphia, Pennsylvania, whose portfolio includes a diverse range of selected market leading and very profitable manufacturing and service companies which together employ over 3,500 people and generate revenues of $3.5 billion.

The core business of Colorcon globally is the design and technical support of advanced coating systems for pharmaceutical dosage forms for immediate, sustained and enteric release. In addition, the company’s technological capabilities include assistance in the development of solid dosage formulations. Pharmaceutical customers are served through strategically located worldwide resources which include 20 Technical Service Laboratories, Manufacturing facilities in 6 countries and direct sales representation in 23 countries on 5 continents. This global network ensures the fast, timely access to the products and services that customers demand.

Colorcon is organised into 4 major and closely linked Regions around the world. The EMEA Region employs almost 330 people and is headquartered at the Dartford, Kent site which is a full manufacturing, distribution, sales and technical facility. Other key regional sales and technical operations serving major pharmaceutical industry customers are in France, Germany, Italy, Hungary, Russia, Spain and Turkey.

This position relates to the need to find and appoint a new Senior QA / QC Manager - EMEA. The role is a rare, high profile and outstanding opportunity for an experienced and proactive professional to lead, manage and continuously develop to the next level a Department key to business success, and play an active broader role as a member of the company’s EMEA Regional Leadership Team.

 

The Position

The Senior QA / QC Manager – EMEA will be a full member of the Regional Leadership Team and therefore will have a complex, high profile, functional and operational, customer facing and strategic business brief to perform.

 

The role is directly responsible and accountable for the overall quality of the products supplied from the manufacturing facility, together with the development, implementation and maintenance of the regional Quality System, and leadership / participation in global quality projects as part of the Global Quality Team. The role has direct responsibility for all quality related staff at the Dartford site including Quality Assurance ( product release and quality systems ) and Quality Control ( raw materials and finished goods ).

 

The Senior QA / QC Manager – EMEA must be positive and proactive and have an extroverted style which blends well with others at all levels and gains their full cooperation, support and respect. The role demands an initiative taker whose commitment to the highest quality levels will help take the function and the company’s performance to the next level and beyond.  

 

Main Responsibilities:

 

  • Department management – prepare, present and agree budgets and plans for the QA and QC functions in support of the company’s business objectives.
  • Promote a customer focused philosophy and lead, manage and develop the abilities, competencies and skills of the site QA and QC  staff.
  • Advocate and forge strong, action orientated and mutually beneficial relationships between quality and operations groups and with customers in the EMEA Region.
  • Manage the development and execution of local QA systems, policies and procedures to meet Colorcon global standards.
  • Coordinate and host all customer and regulatory audits.
  • Manage supplier approval in the EMEA Region and the performance of supplier audits.
  • Manage and perform internal audits and be responsible for the implementation of corrective actions from all audits and investigations.
  • Monitor and analyse customer complaints and ensure satisfactory response to them.
  • Lead and implement change management, continuous improvement programs and other initiatives linked to changes and enhancements to methods, processes and product cycle times.
  • Advocate Quality awareness in the company and ensure consistent focus upon Quality risk management and reduction.
  • Lead and execute all GMP and ongoing procedural training.
  • Perform actively as a member of the Regional Leadership Team; input to the Global Quality Team and participate in or lead key projects.

The Person

Qualifications 

  • A degree or equivalent qualification in a relevant scientific discipline.
  • Membership of the Chartered Quality Institute.

Experience & Capabilities:

  • Substantial proven experience at management level in a senior Quality Assurance or Quality Control leadership role, giving operational and strategic exposure and responsibilities, within the pharmaceutical or related industries.
  • Change Management and Quality Improvement exposure and proven, effective motivational, communication and management skills.
  • Able to work as part of a cross functional regional leadership team and as part of a global quality team.
  • Comfortable with a complex global matrix organisation.
  • Strong familiarity with relevant Quality standards, ie ISO 9001 and 14001, together with Auditing and Certification and Regulatory requirements.
  • Exposure to and familiar with the use of modern Quality philosophies, practices and techniques including FMEA, Kaizen, Kanban, Lean, 5 S, Risk Reduction and Elimination and Right First Time.
  • Organisational awareness with the ability to think and act well at detailed operational and strategic levels.
  • Computer literate.

 Characteristics & Competencies: 

  • Excellent communication, presentation, interpersonal and relationship building skills and attributes.
  • Highly self motivated with initiative, flexibility and a can-do attitude and able to work under pressure to meet deadlines.
  • Outgoing, confident and energetic personality and a good team player at management level.
  • Strong team leader with an empowering style, committed to ongoing personal and team development and improvement.
  • Analytically sound, a problem solver with a practical approach.
  • Confident in interacting at all levels of a business from highly technical development and operational staff to commercial and senior management.
  • Internal and external customer focused approach, willing to go the extra mile to meet needs and achieve customer satisfaction.
  • Well organised, keeps excellent records and documents, makes good use of time and resources.
  • Well presented and professional with excellent verbal skills.
  • Demonstrates values in line with Colorcon’s ethos.

 

To Apply

Please send your CV and current salary details, quoting reference number 7891 to bob.thorpe@kilpatrick.uk.com

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