1+ months

Contractor Quality Lead MGR. Upjohn External Supply Quality

Pfizer
Tokyo
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**POSITION TITLE:**

(title reflected in Outlook and Pfizer Org Chart)

Contractor Quality Lead

**REPORTS TO:** (Manager's Name)

Gaetano Rinaldo

**DATE COMPLETED/ REVIEWED**

12/12/2019

**DIVISION/BUSINESS LINE:**

Upjohn Global Supply

**SUB DIVISION:**

Global Quality Operations and EHS

**DEPARTMENT:**

External Supply Quality

**LOCATION(S):** (indicate all possible locations)

Primary:

Nagoya

**Is this a legacy Hospira position?**

Yes

Other:



**APPROVAL FROM SITE LEADERSHIP:** (required for Cambridge Site)

N/A

**Global Job Structure Information**

(for assistance, see the GJS Navigator )

**JOB PROFILE:** (see GJS Navigator tool)

enter job code or copy/paste from GJS Navigator

**GLOBAL JOB STRUCTURE ATTRIBUTES:**

(Job Family Group, Job Family, Job Category, Job Level, Management Level)

Job Family Group: Quality Assurance and Control

Job Family: 358- QA External Supply

Job Category: Professional

Job Level: P03 - Manager

Management Level: J070

**Grade Information**

(may not be applicable outside the US/PR)

**LOCAL GRADE:**



**GRADE PROFILE:**



**To be completed by Global Compensation (US/PR only)**

Compensation Evaluation required for new or revised roles; work with your HR Generalist to obtain compensation review.

**DATE OF COMPENSATION EVALUATION:**



**REVIEWER:**



**NOTES:**



**ROLE DETAILS**



**NOTE: The following information must be included in the Create Job Requisition process in Workday; all fields can be copied simultaneously and pasted into the Job Description section**



Please provide definitions for all acro nyms. For US/PR, unless otherwise noted, all fields must be completed.

**ROLE SUMMARY**

Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region).



Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.



The Global Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."



Upjohn External Supply Quality is committed to supporting Upjohn Global Supply (UGS) as an innovative and competitive advantage for Upjohn by assuring the quality of products manufactured and packaged by other companies (Contractors) for Upjohn.



Upjohn External Supply Quality is responsible for the Quality management of approximately 80 contract manufacturers, packagers, and supply partners globally.



**ROLE RESPONSIBILITIES**

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

The Contractor Quality Lead Manager is accountable for providing quality assurance management of key contractors for Upjohn and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements.



This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Upjohn and Pfizer. (S)he will operate as spokesperson for External Supply Quality and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer and Upjohn quality requirements with contract manufacturers.



The Contract Quality Lead Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, Internal sites and R&D) and will lead and participate in virtually based cross functional teams. (S)he will report to the Director/Team Leader Upjohn External Supply Quality.

**QUALIFICATIONS**

Indicate basic and preferred qualifications:



+ **Basic Qualifications** are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education/licenses/certifications, location, relevant experience, technical and/or other job-related skills. Basic qualifications determine minimum requirements that applicants must possess to be qualified for the role; anyone who does not meet basic qualifications for the role will not be interviewed or eligible for hire.

+ **Preferred Qualifications** are job-related qualifications that may be indicated in addition to basic qualifications; they are not absolutely required for performance of the job but are desired and further describe the education/skills/experience sought for the position. Preferred qualifications enhance a candidate's ability to perform the job.



+ Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting

+ At least 4 years of Product Quality Assurance experience in a GMP environment

+ Experience with external suppliers/contractors is preferred

+ Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms

+ Command of English language required and multi-lingual is beneficial.

+ Strong verbal and written communication including presentation skills

+ Shows strong negotiation skills and is diplomatic in communication with internal and external customers

+ Demonstrated ability to manage multiple projects

+ Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader

+ Has excellent organization skills

+ Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor

+ Developing personal leadership to manage cross functional projects

+ Developing ability to resolve conflicts

+ Takes initiatives and is proactive, persistent

+ Has a broad GMP and technical know-how to handle emerging issues



**PHYSICAL/MENTAL REQUIREMENTS**

(not all roles will have physical or mental requirements)



Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity.



Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis



Note: Do not include requirements of the role that are generally applicable to most or all jobs at Pfizer, such as "ability to communicate," "ability to work on teams", "office job involving use of computer", etc.



PHYSICAL/MENTAL REQUIREMENTS



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

(not all roles will have non-standard work schedule travel, or environment requirements)



Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.



+ Up to 20 % travel required



**OTHER INFORMATION**

The following information, if applicable, must be manually inserted into the job description for transparency:



+ Relocation eligible

+ Internal candidate identified

+ Eligible for employee referral bonus

+ Posting expiration date (if determined)



This can be edited or added after the requisition has been created



OTHER INFORMATION



**ORGANIZATIONAL RELATIONSHIPS**

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.

The incumbent will have strong business line connections to multiple internal and external stakeholder groups. Specifically, internal relationships with both Pfizer and Upjohn organizations such as External Supply, Pfizer Global Supply and External Supply Quality, New Business Development, Global Technical Services, Global Quality Operations and EHS, Internal Site Leadership teams, Medical, Safety and Legal teams.

The Contract Quality Lead will also operate as spokesperson for Pfizer and Upjohn and will spend a significant period of time developing external relationships, independently negotiating issues, developing and communicating quality requirements with contract manufacturers, distributors and partners.



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



Regulatory Affairs
Posted: 2020-02-06 Expires: 2020-04-09

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Contractor Quality Lead MGR. Upjohn External Supply Quality

Pfizer
Tokyo

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