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Senior Associate, Aseptic Manufacturing Compliance

Pfizer


Location:
Andover, MA
Date:
11/22/2017
2017-11-222018-01-01
Pfizer
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Job Details

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.







The Andover Liquid Dosage Manufacturing (AN-LDM) Compliance Senior Associate is responsible for oversight of the compliance program and its associated elements for Pfizer's state-of-the-art large molecule early stage clinical drug product manufacturing facility. This is a dynamic role focused on ensuring alignment and adherence with internal and external quality and regulatory standards. Additionally, the Sr. Associate in Drug Products Compliance will have primary responsibility for supporting audits and the implantation of quality initiatives and the validation program.







The Sr. Associate in Drug Products Compliance will support training and documentation alignment. They will also lead facility tours and manage overview presentations of the facility. This role will emphasize strong cross functional interactions and a close working relationship with the groups in the Clinical Manufacturing Organization.







**ROLE RESPONSIBILITIES**







+ Participate/lead in cross-functional teams, working effectively in a highly matrixed team environment to advance Pfizer's clinical portfolio.



+ Provide oversight and manage validation program and manage implementation of new systems closely working with supporting quality groups.



+ Manage formalized risk assessment activities supporting aseptic operations, multiproduct and simultaneous production as well as safety elements.



+ Lead manufacturing compliance forum to monitor health of and adherence to quality systems and report status to overseeing quality council.



+ Provide input supporting revisions to Pfizer Quality Standards (PQSs) and complete gap assessments against established standards.



+ Evaluate regulatory findings and trends to provide recommendations of items which can be impactful to LDM and work to implement required changes.



+ Represent the AN-LDM in internal network groups including: The PharmSci and PGS Sterile working group, Aseptic Operations Forum, visual inspection working group and The Container Closure Integrity (CCI) team.



+ Deliver progress reports and presentations and ensure that management is aware of the current compliance status and progress to meeting commitments..







**BASIC QUALIFICATIONS**







+ B.S. in an engineering, scientific or related discipline



+ 10+ years of experience in aseptic pharmaceutical operations/support.



+ Experience in a Quality role is preferred.



+ Manage continuous improvements initiatives using technological innovation and application of first principles.



+ Demonstrated experience in a matrix team environment and interacting with Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.



+ Strong attention to detail, along with excellent communication and collaboration skills.



+ Strong decision-making skills, routinely demonstrated in highly complex environments.



+ Must be comfortable with ambiguity yet able to quickly discern where to focus to deliver desired outcomes.







**ADDITIONAL OFFER DETAILS**







+ **Last Date to Apply for Job: January 23, 2018**



+ Additional Location Information: Andover, MA



+ Eligible for Relocation Package: Yes



+ Eligible for Employee Referral Bonus: Yes







**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.







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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