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Director Site Quality Assurance


McPherson, KS 67460
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Job Details


The Site Quality Assurance Director partners with Site Operations to drive regulatory excellence ensure a supply of quality products from the site which are compliant with regulatory requirements to meet customer needs and develop talent.

The role is accountable for the product quality, regulatory compliance, quality systems, and processes for the site. The scope of this role also includes quality budget and resources planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives, and quality specific projects. The role is accountable for providing leadership to the site in establishing compliance with marketing authorizations of all materials, packaging components, in-process and final commercial products with established specifications, compliance with regulations and other applicable standards.


Relationships: Achieves Quality and business results through Partnerships at site/cross site level. Is an active member of the Site Quality Leadership Team.

High Performance Culture: Creates a high achieving Quality team with goals and values aligned with other team members and operations, collaborative team environment, and high-performance culture

Talent Management Focus: Oversees the conduct of Talent Management programs to develop future Pfizer leaders and the creation of robust succession plans for the Site. Directs, oversees and participates in the recruitment, selection, promotion, termination and performance management of site personnel in leadership and critical roles. Leads the following activities:

Job Descriptions for Reports

Training curricula/records

Development Plans

Performance Appraisals

Coaching of Direct reports

Assures the organization has the appropriate scientific, regulatory and technical product expertise to assure sound decision making and business continuity.

Issue Resolution: Ensures the creation and implementation of clear and timely action plans for issue resolution with appropriate escalation, communication, and closure.

Regulatory Excellence: Ensures sustainable regulatory excellence through systems, science, people, and continuous process improvements. Ensures a favorable site regulatory profile through constant inspection readiness programs; ensures successful Regulatory inspections. Creates effective relationships with Regulatory agencies to create trust and credibility. Prepares the site for changes to regulations.

Quality Systems: Ensures compliant site Quality Systems and marketing authorizations.

Quality Plans: Ensures the creation and execution of the Site Quality Master Plan and Site Quality and Compliance annual business plan.

ICH and Industry Standards: Drives understanding of ICH Q8, Q9, Q10 and other appropriate industry standards across the site organization. Follows actively and anticipates impact of emerging regulations on site operations and prepares site for implementation and change, as appropriate.

Product Disposition: Ensures independent and timely product disposition using validated processes, analytical methods, and documented decision making processes.

Technology and Science: Holds self and others accountable for making decisions, solving problems, or driving improvements through a sound understanding of the technology and science of the products.

Operational Excellence: Drives innovation and continuous improvement through Operational Excellence in all Q&C activities and supports OE throughout the site.

Analytical Development: Fosters science through the establishment and work of the Quality Analytical Development function

Other: Ensures process in place for process, capital and functional review for Quality and EHS



Advanced degree in pharmaceutical science, biology, chemistry, engineering or related science. At least 15 years work experience in the pharmaceutical Industry preferably within different functions within Operations, Quality & Compliance, EHS and/or Research and Development with 10 years of supervisory experience, preferably at multiple sites.


Ideal candidates will have prior experience in most, if not all, of the following and employees developing into this role should develop experience and demonstrated success in the following:

+ Making sound and effective decisions under pressure

+ Managing a Quality/Compliance function with product release responsibilities

+ Demonstrated knowledge and applicability of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems.

+ Experience in at least two quality and/or science areas

+ Working in functions outside Quality e.g. Technology, Validation. Operations, Regulatory

+ Working with other manufacturing and R&D sites to understand a broader perspective

+ Exposure to Regulatory inspections

+ Working with multicultural, cross-functional work teams

+ Advancing a quality culture in a manufacturing environment

+ Evaluating and continuously improving site Quality Systems

+ Managing managers and teams

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Other Job Details:**

+ Last Date to Apply for Job: March 9, 2018Eligible for Relocation Package - YES

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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