Manager- Quality Assurance

Kalamazoo, Michigan

This job has expired.

Role Description

• This role is accountable for the oversight and execution of Quality Management Systems and compliance of

Biopharmaceutical development projects. The role serves as a QA point of contact for Biopharmaceutical

product development activities.

• Support R&D development portfolio working with project teams to establish/implement quality systems

complying with applicable regulations, company's quality procedures, standards, and policies.

• Continued maintenance of the Zoetis Quality Management System and overseeing the day-to-day tasks

within the Quality Assurance department.

• Maintaining compliance to GMP standards and driving Quality throughout the business.

• Review & approve product development related Quality documentation (eg. master and executed batch

manufacturing records, analytical method validation and technology transfer, product development report,

release and stability analysis repot and data, failure investigations etc.)

• Quality oversight and keep tracking for timely closure of Quality Management System( QMS) documents.

• Working with external CRO's by coordinating, managing, scheduling, and ensuring the shipment/provision of

necessary materials for the study.

• Ensure the adequate archival of documentation and document traceability.

• Provide support to Regulatory CMC by review of Chemistry, Manufacturing & Controls (CMC) section of

dossier and review of supplier Veterinary Master File(VMF)/ Dossier as applicable.

• Internal audits/vendor audits/ CRO audits expected as part of the role.

• Support the Project team/ Zoetis manufacturing team/ CRO/CMO as per business requirements.

• Represent Quality in Due Diligence activities.

• Responsible to review applicable SOPs, guidelines etc.

• Provide Quality & GMP related trainings to internal and external partners.

• Promote a culture of quality awareness.

Knowledge/Experience Desired

• Master's degree or equivalent in Life Sciences, Chemistry, Pharmacy and Engineering with 10-12 years

relevant experience in the Quality function. Candidate with working experience in Biopharmaceutical

(QA/QC) is preferred.

• Understanding and handling experience in line with ICH, EU GMP and USFDA guidelines/regulations

relevant to product development & GMP manufacturing.

• Knowledge of good documentation practice and document management.

• Self-Motivated individual with excellent communication, presentation, and scientific/technical writing skills.

Ability to work in interdisciplinary and/or cross-cultural teams.

• Recognizes and builds support for change. Engages in constructive conflict. Ability to fit in well culturally in

a complex organization.

• Candidate must be able to quickly adapt to changing project needs, assignments, and environments.

Thorough understanding of development activities and processes in pharmaceutical industry. Good project

management, time management, and decision-making skills.

Full time



Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis 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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at site, or (2) via email to/from addresses using only the Zoetis domain of "". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

This job has expired.

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