16 days old

Site Investigation Lead

Pfizer
St Louis, MO 63103
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**ROLE SUMMARY**

**This position serves as the Site Champion for investigations, is responsible for the quality and compliance oversight of the Investigations program and is actively engaged in strengthening the site investigation culture through coordinating, planning, assessing, and reporting investigation effectiveness. This role is instrumental in developing the overall site investigations strategy for reducing repeat manufacturing and safety investigations/incidents, influencing site leadership, and enhancing a Quality and EHS culture that drives to zero defects.**



**ROLE RESPONSIBILITIES**



+ Own and ensure a robust investigation process for the site, through the consistent and effective use of investigation system SOPs 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, analyze related metrics, seek out trends and discuss opportunities regularly at the SQRT and/or SLT meetings.

+ Provide Quality oversight for project-related investigations and issues and advise on policies and procedures.

+ Review and approve manufacturing investigations in the QTS system. Perform disposition of materials related to investigations.

+ Work with site leadership and partner with center colleagues (QSSS/TL&C/OpEx/EHS) to develop a robust site strategy and action plans for improving the Investigation system, as areas of opportunity are identified.

+ Implement and oversee the Global Investigations Training Curricula for QO and EHS investigations; ensure 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. Work with Center resources as necessary.

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

+ Collaborate with the site PHP Lead, site training lead, site OE colleague, site EHS colleagues to ensure that all investigations training, tools and methodology are consistently used, including DMAIC methodology (M1/M2/M3) to ensure adequate RC analysis and CAPA, and PHP to reduce and prevent Human Error.

+ Participate regularly and contribute to global discussion groups (PHPCIG, MINE meeting, ASK-MINE, others) sharing information between the groups and the site colleagues, replicating practices, and promoting/enabling site colleague participation.

+ Work as needed with QS&C (QSSS/TL&C), OpEx and EHS SME's to keep up to date with activities regarding the Investigations system.

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

+ Work closely with QTS MIR/LIR/CITI User Council Representatives to identify opportunities for system improvements, review proposed updates, and communicate planned changes to site QTS users.



**BASIC QUALIFICATIONS**



+ Education: BS/MS in Chemistry, Microbiology, Engineering or other science related discipline

+ Experience: Minimum 7 years pharmaceutical experience.

+ Requires expertise in all types of investigations (ERs/QARs/LIRs/Complaint Investigations and EHS investigations) and DMAIC methodology.

+ Quality Assurance experience required with focus on Quality Risk Management.

+ Requires Project management, team leader/project leader/and coaching skills.

+ Experience with QTS system preferred.

+ Must have strong interpersonal and influential skills.

+ Must be willing to embrace innovation and change in order to implement solutions.

+ Independently and consistently produces quality work. Must be able to work in a team environment. Must work under short timelines while maintaining quality work.

+ Must have effective written and oral communication skills. Must be able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel. Writes clearly, accurately, and can produce technical documents.

+ Must have strong data analytic skills.

+ Works with integrity and works ethically. Maintains confidentiality.

+ Supports organization's goals and values. Willing to work together to achieve a common goal.

+ Produces analytical work of high quality. Looks for and suggests ways to improve and promote quality.

+ Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements.



**PHYSICAL/MENTAL REQUIREMENTS**



Ability to perform complex data analysis



While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Position requires regular onsite attendance



Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.



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.



Travel between Brentwood and Westport locations required.



The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



Last date to apply for job: June 18, 2021



**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.



**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.



Quality Assurance and Control



\#LI-PFE
Posted: 2021-06-04 Expires: 2021-07-12
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Site Investigation Lead

Pfizer
St Louis, MO 63103

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