Sr. Specialist Quality Operations (Secondment - 12 Months)

Pfizer•Kalamazoo, MI

2d•Onsite

About The Position

This role is a 12-month secondment opportunity designed for high-performing Operations and Quality professionals seeking to broaden their experience and gain meaningful exposure to the partner organization. The intent of this assignment is to deepen cross-functional knowledge, strengthen collaboration between Operations and Quality, and develop future leaders with a strong end-to-end understanding of drug product manufacturing and compliance. This posting is for current Kalamazoo Drug Product Operations colleagues who are looking for experience and growth within the Quality organization. The successful candidate will be fully integrated into the drug product quality organization and will perform the day-to-day responsibilities of the role, serving as an active contributor to operational unit, compliance, and continuous improvement initiatives. This is a hands-on assignment with accountability for delivering results while gaining practical experience working across multidisciplinary teams. This secondment provides a unique development opportunity to build technical depth, project leadership capability, and regulatory awareness while contributing tangible value to the business through operational improvements and sustained compliance.

Requirements

Bachelor's degree with at least 3 + years of experience; OR a Master's degree with more than 1 + year of experience; OR an Associate's degree with 6 + years of experience; OR a high school diploma (or equivalent) and 8 + years of relevant experience.
Pharmaceutical experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements.
Strong oral and written communication skills.
Ability to influence various stakeholders and gain consensus.
Basic project management skills
Exposure to and knowledge of Six Sigma and PHP investigational techniques.
Permanent work authorization in the United States.

Nice To Haves

Strong investigational experience.

Responsibilities

Independently provide real-time Quality impact assessments and decisions on Drug Product issues.
Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary.
Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations.
Participate in QRM assessments that gain approval through Site and Area QO Management.
Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc. as appropriate.
Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts.
SME support during regulatory audits including contributions to strategies to successfully respond to auditor concerns.
Participates in internal GMP audits.
Effectively communicate complex technical issues to all levels of Management (including outside of Quality).