Quality Site Head

Purpose:

The Quality Site Head is responsible for the effective operation of QA functions at the manufacturing plant including Incoming Quality Assurance quality control testing of the product Manufacturing Quality Assurance of inprocess and finished product including batch record auditing and disposition. Validation of product processes and equipment. Leads a team of quality professionals who are responsible for compliance and quality oversight for the plant operations.

Responsibilities

Responsible for all aspects of quality assurance and quality control related to product(s) produced at the plant. 

Represents the decisionmaking authority on all aspects of the Quality and Regulatory compliance program for the site.

Provides overall quality direction to the Site Director and the plant staff on the product fitness for use criteria.

Ensure that product within the plant is consistently manufactured in conformance with product requirements and all applicable regulatory requirements.

Manages a quality organization of up to 7 direct reports.  Directly responsible for the effective organization administration training and supervision of the Quality Department.

Provides regulatory and technical guidance to all departments in the plant.

Represents the site in matters associated with governmental / regulatory investigations and inspections.

Responsible for the development and administration of the annual operating budget of the Quality Department.

Followup on short term and permanent corrective action for all nonconforming products or situations with potential impact on product performance. Responsible for the timely resolution of product performance issues and implementing corrective and preventive actions.

Incumbent is responsible for quality decisions related to all aspects of the plant operation including facility design and product specifications and to ensure that the plant meets all cGMP and other regulatory requirements.

Qualifications :

Bachelors Degree required preferably in Physical or Life Sciences Pharmacy or Engineering

Certified Quality Engineer or formal training in quality engineering or statistics is preferred

Qualified Professional (QP) is strongly preferred for plants in Europe

10 years of combined experience in Manufacturing QA R&D in pharmaceutical biologics device or chemical industry 6 years Quality or Manufacturing large group supervision 3 years Quality Management experience 3 years

Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products including raw materials manufactured at the plant.

Must be familiar with use of statistical quality systems electronic document management and laboratory information management.

Must also be familiar with QA policies as well as cGMP and other regulatory requirements.

Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing materials management engineering product development Quality Systems Product QA and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on daytoday situations.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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Work :

No