Pfizer Sr. Associate QS&OS Upjohn External Supply Quality in Tokyo, Japan
(title reflected in Outlook and Pfizer Org Chart)
Sr. Associate - Quality Systems and Operational Support
REPORTS TO: (Manager's Name)
DATE COMPLETED/ REVIEWED
08 Jan 19
Upjohn Global Supply
Global Quality Operations and EHS
External Supply Quality
LOCATION(S): (indicate all possible locations)
Is this a legacy Hospira position?
Any EU PGS or UGS location or remote working
APPROVAL FROM SITE LEADERSHIP: (required for Cambridge Site)
Global Job Structure Information
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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: P02 - Senior Associate
Job Code: 603865
Management Level: J060
(may not be applicable outside the US/PR)
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:
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.
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.
Our 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."
Contract Operations Quality Assurance (COQA) drives excellence in Quality by maximizing our Partner collaboration to ensure Patients confidence in our Products.
COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.
The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) and management of routine product complaints for the Drug Products and Drug Substances (APIs) manufactured by Contract manufacturers.
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.
Initiate, review and approve regulatory changes through PDM for changes initiated by or impacting COQA managed Contract manufacturers.
Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Pfizer Country Offices (for Single market products) for the various regulatory activities involving COQA managed Contract manufacturers.
As the Regulatory Compliance and Product Complaint Expert, participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for ES/COQA managed Contract manufacturers and if needed, participate in Site Quality visits at the Contract manufacturers.
Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the COQA Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues as per our procedure and Standard Work guidance.
Support and Perform Lot Disposition for Biotech products in collaboration with other functions.
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.
Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline
Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Masters degree)
Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms
Good command of English language and multi-lingual is a benefit
Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment
Able to report remotely and deliver work independently
Show strong negotiation skills and customer focus
Is diplomatic in communication with internal and external customers
Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader
Take initiative and be proactive
(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.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Up to 10% travel required
The following information, if applicable, must be manually inserted into the job description for transparency:
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
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 position will report to the Upjohn External Supply Quality Leader, and will work collaboratively with Contractor Quality Leads and External Supply Operational Managers.
Indicate the Average Budget or Revenue accountability, as applicable.
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
The position has no direct reports
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control