RQA GMP Sr. Manager

• ROLE SUMMARY
• Regulatory Quality Assurance (RQA) is an independent Quality audit function accountable to identify risks and non-compliance associated with Pfizer’s GxP regulated operations. Within RQA, the GMP Audit function is responsible for performing GMP audits to Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers involved in the manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide. The RQA GMP Audit function is accountable to ensure Pfizer manufacturing operations are compliant with all applicable global regulations and GMP /GDP standards, as well as Pfizer Quality Standards. The RQA GMP Audit function is required to understand GMP regulations worldwide and apply this expertise when performing audits, to provide assurance against regulator’s interpretation and expectations for compliance with cGMP/GDP requirements. RQA is part of the Pfizer Corporate Compliance Division.
• The Senior Manager, GMP Audit position is responsible for leading and performing independent GMP audits and assessments of Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers. The Senior Manager, GMP Audit will assess processes, systems and procedures, to evaluate their quality performance against established standards and regulatory agency guidelines. This position leads independent GMP/GDP audits and inspection preparation activities, resolution of audit and inspection findings, and liaises with appropriate site quality and above site quality teams through all stages of the audit lifecycle. The Senior Manager, GMP Audit may lead or participate in complex cross functional projects. This position contributes to enabling a culture of innovation, excellence and continuous improvement of the company’s Quality Management System, through engagement with Pfizer site audit teams to incorporate audit outcomes and best practices across the Pfizer manufacturing and supply network. Quality: http://www.pfizer.com/about/quality
• ROLE RESPONSIBILITIES
• As assigned, independently lead or participate in GMP/GDP audits and assessments of Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers involved in the manufacture, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide, including Pfizer Country Office locations with GMP/GDP responsibilities.
• Assess if the auditee is executing operations in compliance with cGMP/GDP requirements and guidelines, Pfizer Quality Standards and Quality Agreement requirements and Standard Operating Procedures.
• Assess whether employees are being properly trained for their responsibilities, as well as the adequacy of the facilities and equipment used for manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products.
• Communicate relevant quality and business information to the facility, contract manufacturer, supplier or GMP/GDP service provider audited, in an effort to maintain and enhance the relationship between the auditee and Pfizer.
• Interpret regulatory and business challenges and best practices, report risks or weaknesses that could lead to cGMP/GDP compliance issues, and recommend required improvements or solutions.
• Lead or participate in GMP audits at Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers. Responsibilities for these activities include but are not limited to:
• Lead negotiations with auditees to schedule audits
• Lead audit preparation activities including gathering of and review of auditee’ relevant quality and performance metrics to determine risk-based audit scope
• Lead the audit execution, or actively participate in the audit execution as directed by the lead auditor
• Lead the preparation of audit reports
• Lead the review and evaluate the adequacy of the auditee response to audit findings
• Perform audit follow-up activities as required or as directed by leadership
• In appropriate situations, initiate reviews through consultation and agreement with others, including subject matter experts
• Maintain the appropriate audit database with relevant records and information pertaining to the lifecycle of assigned audits.
• Maintain and expand current knowledge of applicable laws, regulations, guidelines, internationally recognized standards and other pertinent policies, procedures, and standards that could impact the auditee’s operations.
• Liaise between auditee and the appropriate Pfizer groups, to ensure that all pertinent information that could have an impact on the auditee’s or Pfizer’s business (e.g., auditee’s regulatory inspection activities or significant changes) are requested, provided and documented.
• Lead or participate in due diligence assessments as required to assess auditee’s Quality compliance.
• As assigned, aid the auditee in preparing for upcoming regulatory inspections.
• Apply technical knowledge to influence the design, planning and execution of cross functional projects.
• Able to collaborate proactively with leadership, site personnel and subject matter experts, to enable a culture of excellence in independent objective audits and effective CAPAs.
• Develop cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, risk-based analysis, critical thinking and innovative problem solving.
• Lead or participate in department wide initiatives to advance the business strategy of the GMP audit function.
• QUALIFICATIONS
• Required Qualifications:
• Bachelor’s Degree in pharmaceutical sciences or equivalent required.
• Minimum 10 years of progressive, challenging experience in the biopharmaceutical industry required, inclusive of quality control / assurance, manufacturing and GMP auditing (may include Product Development).
• Proven knowledge and experience in GMP auditing of at least 3 technology platforms and areas of specialization such as small molecules, biologics, medical device combination products, active pharmaceutical ingredients, aseptic operations, non-aseptic operations, laboratory operations (chemistry, microbiology, specialized), advanced therapies, computerized systems, software as medical device, good distribution practices, and Pfizer country offices.
• Demonstrated ability to apply the following competencies and soft skills: business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills); leadership skills (persuasive communication, active listening, active learner); relationship skills (stakeholder management, social perceptiveness, relationship building); and supporting technical skills (technical writing, digital acumen, data analytics).
• Must understand the elements and requirements of the Quality Management System at the Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers audited.
• Has a strong understanding of relevant regulatory and audit frameworks that apply to biopharmaceutical operations, has in-depth knowledge of cGMP/GDP requirements and expectations, is familiar with global regulations and internationally recognized standards (e.g., FDA, EU, TGA, PIC/S, ISO), and is capable of understanding and reacting to emerging regulations and business / regulatory trends.
• Critically evaluates information from the auditee and is able to identify risk areas in the field. Has the ability to recognize symptoms of problems or situations that require further evaluation, and analyze symptoms to determine potential causes and identify possible solutions.
• Is able to make clear recommendations and communicate effectively. Can independently determine when input from subject matter experts is necessary. Anticipates potential objections and influences others to ensure appropriate outcomes.
• Can effectively cope with change during an audit. Is able to lead a diverse audit team and effectively interact with personnel of multicultural backgrounds. Has the ability to communicate and interact with colleagues and business partners at all levels of the organization.
• Actively leads or participates in cross functional teams for significant and complex projects, and contributes towards outcomes that promote innovation and excellence.
• Is able to assess quality and compliance risks in the field and communicate potential non-compliance matters to Pfizer senior leadership, vendor management and technical staff.
• Adept at managing multiple tasks and changing assignments based on changing priorities. Takes the initiative and is willing to proactively propose and execute tasks as needed.
• Has the ability to work independently and work well in global audit teams as a lead auditor or participant, and is an effective communicator to peers, managers and leadership inside and outside the company.
• Has good organization skills for audit preparation, execution and report issuance in adherence to procedural requirements. Actively works to achieve a balanced audit plan, supportive of urgent audit requests and flexible to changes.
• Write audit reports to reflect the required style and content, with meaningful findings levelled appropriately, and applying ‘write right’ and ‘right first time’ principles.
• Ability to conduct ad hoc GMP assessments (e.g., data integrity, quality culture, due diligence, mock inspection) as required to support business needs.
• Preferred Qualifications:
• Recognized audit certification (e.g., ASQ) is desirable.
• Experience in shop floor quality assurance is desirable.
• BoH / Notified Body experience is desirable.
• Knowledge of Medical Device Regulations is desirable.
• PHYSICAL/MENTAL REQUIREMENTS
• Primarily a field-based position which includes walking and lifting to assess quality and compliance risks.
• #LI-PFE #LI-REMOTE

Work Location Assignment: Flexible

Additional Information 

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland. 
• Please note there is no relocation support available for this position 

How to apply 

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you! 

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. 

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. 

Quality Assurance and Control

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