Responsible for providing overall leadership and direction for the Quality function at the Swords site. This position directs all phases of the quality function including, in process and finished product release testing and quality management. The position also directs Swords site compliance with worldwide regulatory requirements and Quality Systems. Ultimately, this position is responsible for the quality of all products manufactured or packaged at Swords. The incumbent of this position is also responsible for managing the quality function including interacting/developing relationships with regulatory agencies in Ireland and globally. Incumbent must command broad knowledge, interpretation and application of worldwide rules and regulations governing Merck’s manufacturing activities.
The incumbent must have strong technical and leadership skills which will position them as a recognized leader at the site.
Key Accountabilities:
•Required to comply with Merck Global and Site Policies, Procedures and Guidelines, regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
•The level of Authority and Responsibility is described in Various Site Policies and Procedures. Responsible for:
a.Attending and successfully completing applicable GMP training, including training in local operating procedures.
b.Ensuring suitably training to perform the job.
c.Ensuring that this training is accurately recorded in training record.
d.Ensuring that the job is performed in accordance with the training and in compliance with procedures relevant to the role/activity.
e.Bringing to the attention of management any violation in cGMPs and/or other concerns which may effect the safety, efficacy, or purity of Merck product.
•As a People Manager to provide full support to the above responsibilities to ensure that employees are suitably trained to perform their assigned tasks on an ongoing basis.
•As the holder of this role responsible for making major GMP decisions which may have a significant impact on the site and our customers, therefore to have the authority to act within this responsibility with due care and diligence. Should any GMP decision arise which is within the scope of the role then it must be referred to a higher authority.
•Reports to Senior Director, QO Mid & South Europe Lead and receives general direction on policy, goals and objectives. Functions independently at site level and with dotted line reporting relationship to Swords SDO, on general operational matters, and provides definitive decisions on matters of product and raw material release or rejection. Assures adequate staffing and skills within Quality organization to provide timely release of products to the marketplace. Keeps Senior Director, QO Mid & South Europe Lead informed of all major issues.
•Assures the preparation, review and approval of all required records, reports, protocols for all products to be submitted to the government agencies for release of material to the market. Is responsible for the maintenance of adequate processing and quality control records on all approved production procedures in conformity with government regulations. Acts as point of contact with regulatory agencies, as required.
•In a Lean environment , directs all activities of site Quality Operations for the control and release of MMD produced product. Responsible for their safe and effective performance and assures that the various functions are carried out in accordance with production schedules, requests for services, and established standards, as well as all governmental regulations and Quality Operations policies. These functions include inspection, sampling and testing of raw materials, components and finished products; in-process testing, general service testing; complaint and returned goods handling; and evaluation of process change materials in accordance with GMP regulations.
•Gives broad direction and specific objectives to his subordinates and regularly reviews progress to ensure all Quality Operations objectives are met.
•Routinely takes decisions on matter of policy, procedure and product quality.
•Works effectively as a member of the Swords site management team to ensure effective introduction of new products and routine achievement of required customer service levels.
•Consults with the Senior Director, QO Mid & South Europe Lead and other key Divisional personnel as required regarding the quality of products and supplies, technical and scientific information as requested, and takes appropriate action as required to comply with current Good Manufacturing Practices.
•Identifies capacity problems and productivity improvements and submit recommendations for appropriate headcount, capital and operating expense.
•Collaborates with all other departments at Swords as well as Quality, Technical Operations, staff groups at other MMD sites and External Manufacturing.
•Establishes an open management style that models Merck Leadership Standards. Recruits, develops and directs high quality staff to establish a flexible, motivated Quality Operations team in order to achieve a strong compliance culture.
•Promote a strong site quality and GMP compliance culture, supporting a quality council, quality improvement projects ( eg Permanent Inspection Readiness , Right First time , Significant investigation capabilities ) and customer-oriented measures.
•Aggressively implement new technologies and Lean initiatives such as 5S within laboratories to drive continuous improvements and productivity .
•Manages Quality Operations to operate within established headcount and profit plan limits.
•Controls and authorises production processes, operating procedures and printed materials to ensure fitness for use.
Directs and controls projects within Quality Operations and ensure full Quality Operations participation in other site, EMEA and divisional projects.
Job Dimensions:
-Seven direct reports, namely:
oAnalytical Laboratory Manager
oMicrobiology Laboratory Manager
oStability Manager
oQuality Systems Manager
oQualified Person Manager
oRegulatory Affairs Manager
oQuality Operations PA
Department size of 100 people approximately
Desired Skills & Experience
Skills
•The job holder should be a qualified Chemist or Pharmacist and a registered Qualified Person with experience in pharmaceutical processing, analytical and quality assurance.
•Ability to manage and provide strong, clear and effective leadership within a multidisciplinary, multinational environment yet also operate within and nurture a team culture.
•Commitment to high standards of GMP compliance and product quality.
•Ability to operate at strategic and site level.
•Capable of operating independently yet ensuring good upwards communication is maintained at all times
•Excellent written and verbal communication skills
•Excellent problem solving skills
•Strong interpersonal skills
•Ability to take tough decisions and to deal with complex situations
IF YOU ARE INTERESTED IN THIS OPPORTUNITY, PLEASE EMAIL YOUR DETAILS TO elena.matsuura@merck.com
