13 days old

Site Investigation Lead

Pfizer
Tunas, MO 65764
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**Why Patients Need You** At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.



**What You Will Achieve**



+ Own and ensure robust and effective investigations related to quality and safety deviations/incidents site wide

+ Strengthen the site investigation culture through coordinating, planning, assessing, and reporting investigation effectiveness for all safety and quality deviations

+ This role is instrumental in developing the overall site investigations strategy for reducing repeat manufacturing investigations, influencing site leadership. The colleague might be assigned additional roles in the business excellence function for 20-50% of the time



**How You Will Achieve It** **Site Investigation System and Strategy**



+ Own and ensure a robust investigation process for the site, through the consistent and effective use of investigation system procedures and tools, and strong investigation culture across the site

+ Embrace the "one best way" philosophy by actively performing routine assessments and analysis of the site investigation system through the use of the Investigation Utilization Tool and the Investigation Maturity Scale, analyzing related metrics, seeking out trends and discussing opportunities regularly at the SQRT meetings

+ Work with site leadership and partner with functional colleagues (quality, production, engineering, EHS etc.) to develop a robust site strategy and action plans for improving the Investigation system, as areas of opportunity are identified

+ Ensures effective tracking, completion and escalations of milestones for completion of investigations as per the Integrated Manufacturing Excellence



**Capability Building and Site Collaboration**



+ Implement the Investigations Training Curricula for quality deviations investigations;

+ E nsure ongoing support, active coaching, and the use of the structured on-the-job documents for qualification of new originators/investigators/approvers and for those that may need additional knowledge and skills

+ Ensure sufficient training and coaching resources are available and occur in a timely manner to meet site investigation goals.

+ Ensure that all investigations training, tools and methodology are consistently used, inc l uding DMAIC methodology (Ml/M2/M3)

+ E nsure adequate root cause analysis (RCA), effective CAPA, to prevent repeat deviations and PHP (Pfizer Human Performance) to reduce and prevent human factors resulting in e rrors.



**Global Investigation Sharing**



+ Participate regularly and contribute to global discussion groups sharing information between the groups and the site colleagues, replicating practices, and promoting/enabling site colleague participation.



+ Work as needed with Quality (QA & QC), TLC, and OpEx SME's to keep up to date with activities regarding the Investigations system.

+ Collaborate as needed (along with site PHP rep) with the Regional PHP lead

+ Work closely with network teams to identify opportunities for system improvements, review proposed updates, and communicate planned changes to site investigators



Accountable for:



+ LIR/QAR's closure on time

+ % QAR's with error proofing and error prevention

+ % Repeat QAR's

+ LIR/QAR right first time (or equivalent metrics for assessing quality of investigations)



**Qualifications** **Must-Have**



+ Bachelor degree in Engineering, Science or related discipline from a recogn i zed university

+ 6 to 8 years of experience in a pharmaceutical industry with extensive hands on experienc e in developing and suc cessfully driving/strengthening site investigat i ons strategy/ cultu r e , and a sustained mindset for innovat i on & change.

+ S o m e expertise in a ll type of investiga t ions ( ER/QAR, LI R s, Complaints a nd E H S)

+ Experience with relevant QTS modules & train e d on QAR inve stiga tor c urr i cula

+ Trained on PHP and Qua l ity Risk Management (QRM)

+ Six Sigma Yellow Be lt ce rtified

+ Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity

+ Skills to translate and present visualization of data into a format that can trigger action and business decisions

+ St r ong i nterpersonal and influential sk ills

+ Ability to effectively coach and mentor colleagues

+ Strong oral and written communication skills



**Nice-to-Have**



+ Master's degree

+ Six sigma Green/Black belt

+ Certified innovation facilitator/coach



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Continuous Imprv and Proj Mgmt



\#LI-PFE
Posted: 2021-02-17 Expires: 2021-03-29
Sponsored by:
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Site Investigation Lead

Pfizer
Tunas, MO 65764

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