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Quality Operations Validation Director


McPherson, KS 67460
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Job Details


Responsible for regulatory, process, and product change control at the site. Leads the Validation team, the CMC/SCNM team, and the Change Control team at the site.

Leads a team to ensure that Change Control meets defined quality standards and objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the Validation department.

Provides guidance and coaching to Change Control colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel.


+ QO Technical Knowledge (understand chemistry & reactions, GMP compliance, ,manufacturing site product knowledge)

+ Quality Systems Knowledge (understand related quality and compliance systems including lot release, deviations, change management, validation, documentation, etc.)

+ Operation Knowledge (Supply chain, DP or API equipment & processes to make product)

+ Manage Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.)

+ Understand regulatory requirements and audit strategy

+ Review and approve cGMP Documentation to assure compliance with regulatory requirements

+ Assess Deviation impacts and resolution

+ Review and approve cGMP Changes in accordance with regulatory requirements

+ Review and approve training to assure cGMP requirements are met

+ Manage Resources to meet organizational goals

+ Understand site financial systems

+ Understand Safety concerns and maintain safe environment (5S, ergonomics)

+ Ability to perform GAP assessments for new & revised PQS

+ Ensure participation in company-wide knowledge exchanges

+ Review and approve, where necessary, engineering specifications for facilities and equipment to assure compliance with cGMP.

+ Review and approve validation documents and plans used in the manufacture of cGMP products including related computer systems.

+ Understanding of cGMP requirements associated with Cleaning Validation, Method Validation and Computerized Business Systems Validation

+ Understanding of worldwide expectations related to pharmaceutical validation, including ICH Q2, Q3A-D, Q7, Q8, Q9, and Q10.

+ Ability to apply relevant ASTM standards associated with equipment qualification and process performance monitoring.

+ Ability to facilitate Site Validation Committee.

+ Ability to interface with Capital Engineering processes.

+ Expertise in disciplines of change management, qualified utilities (HVAC, Compressed Gases, WFI/PW, etc.), equipment qualification, automation validation, and product process validation.

+ Knowledge to provide expertise to Validation Community of Practice, Verification Common Interest Group, and similar company-level benchmarking initiatives.

+ Develop necessary programs to understand and document Critical Quality Attributes for products, Critical Process Parameters for processes, and Critical Attributes for equipment.

+ Ability to facilitate Change Control Review Committee structure for oversight of local equipment/process change control requests.


**Education:** BS in Chemistry, Biochemistry, Microbiology, or related science

**Experience:** Minimum of nine years of QO experience in a cGMP environment

**Communication:** Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies

**Reasoning Ability:** Strong Analytical and problem solving abilities

**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 30, 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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