Senior Manager Auditor
- Recruiter
- Pfizer
- Location
- United Kingdom, United Kingdom
- Salary
- Competitive salary
- Posted
- 27 May 2021
- Closes
- 14 Jun 2021
- Ref
- 4814923
- Job role
- Audit
- Sector
- Pharmaceutical / medical
- Experience level
- Manager
ROLE SUMMARY
Science is the foundation of all that we do at Pfizer. We are seeking a Senior Manager Quality Assurance Auditor who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.
Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations.
The Sr. Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP enterprise processes that span GCP, PV, Regulatory, Medical or are conducted at the Pfizer Country Offices. This role is responsible for GxP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU , ICH, and National regulations).
ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PREFERRED QUALIFICATIONS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Quality Assurance and Control
#LI-PFE
Science is the foundation of all that we do at Pfizer. We are seeking a Senior Manager Quality Assurance Auditor who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.
Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations.
The Sr. Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP enterprise processes that span GCP, PV, Regulatory, Medical or are conducted at the Pfizer Country Offices. This role is responsible for GxP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU , ICH, and National regulations).
ROLE RESPONSIBILITIES
- Independently conduct wide range (non-routine) complex audits (minimal to no oversight - as needed)
- Execute audit strategy and lead process audits
- Act as a reviewer of audit reports from outsourced or routine audits
- Assess audit plans and quality metrics to identify potential areas of risk
- Actively support regulatory inspections as needed
- Identify and drive process improvements
- Deliver awareness sessions with oversight by manager on various GxP topics internally and externally
- Drive interactions with QA colleagues at other Pfizer locations to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QA
- Actively engage in discussions to understand impact of changing needs of the regulatory environment
- Work with RQA colleagues on cross GxP audit plans as required
- Coach colleagues - lead training for routine and non-routine site and process audits
- Advise business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities
- Independently/with minimal supervision demonstrate leadership by providing clients with influence and recommendations to meet changing GxP business needs
BASIC QUALIFICATIONS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Demonstrates comprehensive working knowledge of business concepts and quality operations
- Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge
- Strong use of quality and auditing frameworks and application
- Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system
- Ability to identify trends within data and apply insights to make recommendations and decisions
- Ability to bring recommendations to stakeholders for discussion and input
- Actively directs and progresses efforts to deliver operational improvements
- Exhibits good project management capabilities
- Has domain expertise in 2 or more technical areas
- Ability to work with ambiguity and adapt plan when needed
- Experience evaluating and understanding quality standards or their application
- Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business
PREFERRED QUALIFICATIONS
- Has significant experience (2 levels; operations and auditing required)
- Lead audit teams (2-6 ppl per team)
- Demonstrates stakeholder and conflict management (communications, relationship management)
- Negotiates needs & acquires feedback on audit outcome
- Preferred experience in audits with a background in PV, Regulatory, Process, Digital or other related quality areas
- Expertise in 1+ major areas (PCO, PV, Regulatory, Digital); and 2+ minor specializations OR 2+ major and 1+ minor
- Ability to function autonomously in a matrix model and in a team environment
- Provides training/mentorship to other auditors or SMEs
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- The travel requirement may be approx. 40%
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Quality Assurance and Control
#LI-PFE
Similar jobs
-
New
-
New
-
New