PURPOSE & SCOPE
The Medical Quality Governance Manager (MQGM) drives medical quality, audit/inspection readiness and risk mitigation for in-country/cluster medical.
The MQGM scope spans market areas that are in scope of the Medical Quality Oversight Committee and Cross-Functional Processes with a Medical involvement or inspection risk, based on the agreement with the Business Process Owner, International Medical Quality (IMQ) and/or country/cluster needs.
ORGANIZATIONAL RELATIONSHIPS
The MQGM is expected to interact closely with market & cluster Medical, platform line organizations, other quality and compliance representatives (e.g., Commercial Quality, Supply Chain/Product Quality, Compliance) and is a member of any relevant country/cluster medical and quality/compliance leadership teams or communities (e.g. Country Medical Council).
Internal stakeholders include, but are not limited to; all teams within Medical Evidence Development, Global Medical Quality Governance, International Medical Affairs Leadership & associated functions, Supply Operations Quality, Clinical Development & Operations, Regulatory Quality Assurance, Corporate Compliance, Legal, Corporate Audit, Global Product Development, Commercial Quality, Safety, Regulatory Sciences, Global Privacy Office and Digital.
External stakeholders include – Industry associations, vendors, license/alliance partners.
MAIN RESPONSIBILITIES / DUTIES
Quality Management
Drive Level 1 medical quality oversight and business support at the market/cluster level, aligning with platform lines, as appropriate.
Lead the development of country & contribute to cluster medical quality strategic initiatives based on risk and business needs, in close collaboration with local medical management, IMQ, and other key stakeholders (e.g., platform line management [Safety, Regulatory]).
Execute Global & Local Quality Plans.
Develop, maintain and execute Country Operational Plan initiatives, as applicable.
Demonstrate medical quality value proposition to internal stakeholders and where appropriate, external customers.
Audits & Inspections
Lead continuous medical inspection readiness efforts in collaboration with applicable global inspections management teams and platform line representatives.
Communicate relevant audit and inspection trends to respective country/cluster stakeholders, ensure that applicable actions are taken to address country/cluster gaps.
Develop and maintain the in-country Regulatory Inspection Site Notification Plan.
Coordinate Regulatory Quality Assurance Pfizer Country Organization (PCO) audits and vendor audits (in accordance with IMQ remit), including management of audit Corrective & Preventive Actions (CAPAs).
Support Corporate Audit requests within the scope of IMQ, as appropriate.
Support external inspections as appropriate in partnership with global inspection management teams.
Support maintenance of professional records for CMAO Medical colleagues.
Issue Escalation and Quality Event Management
Drive effectivemanagement of quality events (QE) and CAPAs for PCO scoped QEs within MQGM to remit and act as the Business Line Quality Group role.
Monitor and drive PCO QEs and CAPA performance and improvement efforts.
SOPs & Other Procedures
Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS).
Act as local QMS01 expert and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines.
Develop or support the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04 and within MQGM remit in collaboration with relevant Subject Matter Experts (SME).
Act as local expert on QMS04 and ensure local controlled clinical and medical documents within MQGM remit follow applicable Pfizer policies and procedures and regulatory requirements.
Facilitate local implementation of global Standard Operating Procedures (SOPs) and ensure relevant communication is cascaded accordingly.
Provide input to draft Global SOPs, Policies, Work Instructions (WI) and related training materials offering the country perspective and local impact.
Training
Ensure local training requirements in MQGM remit are included in the appropriate curricula.
Ensure local curricula in MQGM remit are maintained in line with Pfizer standards.
Facilitate local training compliance reporting for country/cluster Medical, where needed.
Act as a local Expert on QMS07 and Pfizer’s Global Learning Management System.
In collaboration with local & cluster management, identify additional training needs on quality related areas (in addition to MEL mandatory requirements); facilitate, support, and conduct additional training for identified areas.
Monitoring
Identify local areas for monitoring (e.g. via quality reviews) in collaboration with country/cluster medical management and IMQ, as appropriate.
Execute monitoring activities as defined by applicable global & local quality plans.
REQUIRED SKILL SET
Education & Experience
Scientific or technical degree is preferred: BS or MS and over 3 years’ experience in compliance/SOP management, auditing, or related field.
Understanding of the local promotional compliance environment.
Appreciation of the regulatory compliance issues relating to the local medical function.
Previous experience in a role involved in the drug development process is valued.
Supervisory experience in a matrixed organization is valued
Knowledge of training design and tools and experience in applying training methodology is considered a plus
Desired technical and behavioural skills:
Fluency in English
Expertise in managing multiple complex projects
Consultancy skills
Ability to work independently
Able to lead without reporting line authority at senior level
Project Management expertise
Excellent verbal, written, and presentation skills
Collaboration, interpersonal and facilitation skills
Continuous Improvement and/ or organizational effectiveness expertise
Display sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization
Collaborate efficiently across functional and country boundaries, respecting communication, functional priorities, and cultural differences in interpersonal relationships
#LI-PFE
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 is committed to celebrating this, in all its forms – 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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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