Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
How You Will Achieve It
Position Purpose
The key role of the Operations Compliance Readiness Quality Manager is to:
- Lead the imported product CFDI (Center for Food and Drug Inspection of NMPA (National medical Products Administration)) inspection on oversea MAH (Market Authorization Holder) responsibilities
- Manage communication between PGS Sites and BOH and with CMO via the corresponding oversight functions.
- Collaborate all related stakeholder to perform self-inspection to ensure Pfizer global and Pfizer local MAH representant quality management system, comply with related legislations/regulations requirements.
- Actively engage in regulatory monitoring, evaluation and influence of emerging regulations and guidelines.
Main Areas of Responsibility / Accountability
Inspection Related:
- Main point of contact of Pfizer China MAH Agent interacting with CFDI for imported products
- Participate CFDI inspection meeting and launch the MAH inspection readiness activities.
- Correctly interpret CFDI inspector requirement and delivery to Pfizer internal related stakeholders for inspection preparation.
- MAH inspection readiness
- Set up inspection readiness contact list
- Arrange BOH inspection training to colleague who will face to inspector including expectation on question-answer interaction and in front of the auditor behaviour
- Coordinate the inspection logistic arrangement include translation
- Coordinate with department include PGS sites/CMO sites and CMO oversight functions to be audited to prepare the documents required and complete translation proofread
- Facilitate all departments include PGS sites/CMO sites and CMO oversight functions to be audited to perform self-inspection to ensure compliance against China related legislations/regulations requirements
- Arrange rehearsal on virtual online meeting
- MAH Inspection Period
- Coordinate with internal stakeholders for inspection logistic arrangement
- Act as auditing leader to coordinate the needs raised from inspector including report/CAPA report coordination
- Identify the potential misunderstanding occurred from oversea colleague to China inspector and China regulation requirement, to seek providing correct answer to inspector, which ensure no finding is resulted from gap of communication.
- Establish good relationship with inspector and Pfizer sites/CMO to ensure obtain correct feedback from inspector then deliver to Pfizer internal group.
- MAH Inspection Closure
- Facilitate with departments include PGS sites/CMO sites audited to prepare CAPA response for findings from CFDI
- Review the CAPA response whether actions plan can meet China related legislations/regulations requirements
- Carry out CAPA response translation proofread
- Submit response to CFDI according to regulation requirement
- Implement all other actions required in internal procedure related to 'Management of Audits and Regulatory Inspections & Significant Verbal Communications with Regulatory Agencies', include notification, daily summary, final summary and gQTS recording etc.
Regulatory Intelligence Related:
- Act as the Regulatory Intelligence lead for China region, responsible for Quality Intelligence via Regulatory monitoring, identification, monitoring, evaluation and influence emerging regulations and guidelines. Engage with CFDI for external advocacy.
- Partnership with cross Pfizer reg intel teams including Global Chemistry Manufacturing Control , etc.
- Communication to QO EHS leadership on China inspection and reg intel and,
- Site support in China for implementation of new guidelines ()
- Inspection Intelligence: Collect and analyze regulatory inspection data and intelligence input from China inspections and use data analytics to trend, etc.
Partner with Global Regulatory Intelligence team to communicate China information within the team and to in scope Pfizer parties
Key Outputs
Measure
No Overdue CAPAs
Compliance to MAH requirements
Regulatory Observations/CAPA report consolidated and aligned with China's regulation expectations
China regulation changes incorporated into appropriate Pfizer Quality Systems / Standards
Qualifications
Technical Competencies
- GMP, MAH requirement & ChP Knowledge. Trained and experienced in GMP and ChP, carry out responsibilities independently for QA management judge, guide, supervise and adjudicative for products quality and management
- IT systems. Experienced with Quality Systems
- Enable to good communication with BOH and interpret the requirement from government
- Technical writing. Ability to lead a technical investigation/audit report and report to all levels of Organization
- Problem solving. Ability to use problem solving skills and tools to identify and eliminate problems as they arise
- Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy
- Takes initiative and ownership to deliver on time without compromising on quality
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Excellent Quality Decision making skills.
- Able to demonstrate good planning and Organization skills
Behavioural Competencies
- Interpersonal savvy. Effective communication with all staff from different levels and builds constructive and effective relationships
- Dealing with Ambiguity. Can effectively cope with change shift gears comfortably can decide and act without having the total picture isn't upset when things are up in the air doesn't have to finish things before moving on can comfortably handle risk and uncertainty
- Emotional Intelligence. Identify, assess and control the emotions of one-self and awareness of others
- Acts Decisively. Makes decisions in a timely manner, makes good decisions based upon a mixture of analysis, experience, and judgment
- Takes Responsibility. Takes personal ownership of responsibilities and outcomes while following through on commitments
- Holds people Accountable. Clearly assigns responsibility for tasks and decisions Sets clear objectives and measures Monitors process, progress and results
- Grow People. Actively coaches and develops teams. .Builds engaged and motivated team. Provides opportunities and experiences to develop skills, competencies and business knowledge
- Able to deliver results with limited resources
Must-Have
- Tertiary Education in Science or related discipline
- A minimum of 10 years GMP quality related experience in Pharmaceutical industry.
- Experience Leading BOH inspection in China.
- A track record of continuous improvement and balancing efficiencies and effectiveness in processes
- Ability to communicate across all levels of the organisation including senior stakeholders
- Ability to manage competing priorities and complex business relationships.
- Use communication to influence and demonstrate the value of the quality organisation.
- Technical writing and reporting
- Excellent written and verbal communication skills both in Chinese & English
Nice-to-Have
- Bachelor degree in Pharmacy, Sciences or equivalent degree
- A track record of continuous improvement and balancing efficiencies and effectiveness in processes.
- Experience in GMP and Quality Compliance
- Experience interacting with China BoH
Work Location Assignment:Remote
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
