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Manager/Team Leader, Quality Compliance

Pfizer


Location:
Franklin, OH
Date:
03/24/2017
Job Code:
1049176-1852
Pfizer
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Job Details

Job Title Manager/Team Leader, Quality Compliance

JobID 1049176-1852

Location: Franklin, OH

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

Provides oversight for the development and maintenance of quality programs, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Activities include assuring compliance with regulatory guidelines, site-level audit of manufacturing and laboratory facilities, validation and qualification system, change management system, data integrity program, and other quality systems.



*Responsibilities*

*Accountable for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.*Accountable for leading regulatory audits and inspection readiness, resolution of audit/inspection findings.*Accountable for activities involved in the evaluation, review and approval of the validation master plan, validation protocols and reports and typically includes developing and evaluating quality process and system standards to ensure compliance with company standards and governmental regulatory requirements.*Accountable for activities involved in quality oversight for change control system, product CMC change control oversight with Regulatory Affairs. *Accountable for Quality Risk Management, APR preparation, expertise and guidance in interpreting policies, regulatory and/or governmental regulations and agency guidelines to assure compliance.*Accountable for the management of the Training program.



*Qualifications*

*BA/BS, or MS in Chemistry, Biochemistry, Microbiology or related science with a minimum of 5 years related experience in Quality Operations. Qualified candidate must be detail oriented and able to make sound decisions. *Strong working knowledge of cGMP with high productivity and ability to multi-task coupled with a low error rate. *Must have demonstrated proficiency in validation, change management and regulatory inspections. *Must have a strong working knowledge of company and regulatory requirements (e.g. ICH). *The successful candidate must also have demonstrated ability to complete and manage projects independently. *The position also requires strong interpersonal, oral, and written communications skills.PHYSICAL/MENTAL REQUIREMENTS *While performing the duties of this job, the employee is exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus*Position requires regular onsite attendance, this position cannot be performed on a remote / telecommute basisNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS *Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements*Must have the ability to work effectively under and manage to strict production, time and performance deadlines*Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays *Minimal travel requirements are expected



*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.





*Manager/Team Leader, Quality Compliance*
*Franklin, Ohio*
*1049176-1852*


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