Packaging and Labelling Quality Operations Senior Manager

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.
This position is a member of the Medical Device and Combination Products (MDCP) Quality Operations team within the Pfizer Global Supply (PGS) organization and provides end-to-end quality assurance support to Pharmaceutical Sciences, Commercial Sites and Global Technical Engineering and Launch (GTEL) for the development, commercialization, and post-launch support of packaging for Pharmaceutical, Combination and Medical Device Products. The incumbent provides quality assurance guidance of Packaging and Labelling for Pharmaceutical, Combination Products and Medical Devices throughout the product lifecycle including development, clinical trials, vendors, complaints, post-market surveillance, regulated body inspections, applicable internal procedures, and other applicable regulatory requirements throughout the product lifecycle.
How You Will Achieve It

• Act as the quality assurance packaging and labelling quality lead supporting products through reviews and approvals of all product lifecycle documentation including development, risk management, quality management systems, change controls, vendor management, and complaints.
• Ensure packaging design, development, commercialization, complaint, and manufacturing documentation of pharmaceutical products, medical devices and combination products meet appropriate regulatory requirements by providing guidance through all stages of life cycle management in accordance with packaging regulations, standards and in compliance with Pfizer Policies, Global Standards Operating Procedures (GSOPs) and Global Work Instructions (GWI's).
• Serve as Owner and subject matter expert (SME) on packaging Global Standard Operating Procedures (GSOPs) and Global Work Instructions (GWIs), internal procedures.
• Provide support for packaging and labelling related quality investigations related to Corrective Actions Preventative Actions (CAPAs), laboratory investigations, external suppliers, or complaints.
• Responsible for working with external contractors related to packaging ensuring consistency and compliance with regulatory expectations and company standards including leading and supporting investigations of significant quality and/or regulatory events associated with external suppliers.
• Monitors changes to packaging and labelling global regulations and ensures policies and procedures reflect applicable changes, implements packaging best practices, and communicates company-wide policies on packaging effectively.
• Identifies, leads development of, and participates in implementation of new processes/programs for packaging continuous improvement.
• Provide support for audits and inspections by FDA, notified bodies, competent authorities, and other third parties for packaging related issues.
• Lead execution of packaging test method development, test method validation, and design verification/validation related test protocols.
• Advise on packaging related test plan writing and execution for design verification/validation and process validation.
• Monitor changes to global packaging regulations and ensure policies and procedures reflect applicable changes, implements quality system best practices, and communicates company-wide policies effectively.
• Responsible for quality oversight of packaging: design verification and validation, usability, process qualification and change control execution, and continuous improvement of the same.
• Packaging Quality Assurance oversight of facility, equipment, computer system validations andchange controls.
• Routinely provides guidance and interpretation of packaging GSOP compliance within PharmSci and PGS and with external partners.
• Manages risk for a broader range of packaging issues based on experience.
• Identifies, leads development of, and participates in implementation of new packaging processes/programs for continuous improvement initiatives.
• Monitors packaging specific regulatory and industry environment, interprets information, benchmarks with others, and shares knowledge.
• Advise customers on complex packaging issues within their line function.
• Able to apply new concepts to many applications or work processes.
• Execute assignments independently, complete complex assignments with little coaching and interface with management as needed.
• Expert in quality investigation techniques and leads complex quality investigations and develops QA decisions. Actively contributes to PSQRT/AQRT.
• Reviews and approves all lifecycle documentation including complex deliverables (multiple systems and devices).
• Has practical understanding of how internal SOPs pertaining to supported line functions are being interpreted locally.
• Proactively seeks global alignment / interpretation in application of policy / procedure.
• Has technical and quality knowledge on later phase product life cycle strategies (e.g. process validation, ICH stability, etc.). Leads and advises as needed.
• Serves as packaging quality SME in internal or external audits.
• Maintains a broad understanding of the business and has a positive impact on global work streams.
• Evaluates highly complex packaging quality and performance issues on projects or with vendors and provides suggested issue resolutions.
• Experience managing packaging laboratory operations and regulatory/accreditation compliance.
• Participates as an external influencer at conferences or standard committees as Pfizer packaging SME

Qualifications
Must-Have

• Bachelor's Degree or equivalent in a scientific/engineering discipline.
• Broad technical knowledge related to the packaging design and lifecycle management as applied to pharmaceuticals, medical device or drug combination product platforms, design controls, risk management, Packaging ISO, ISTA, AAMI and ASTM, and working knowledge of 21CFR 820, ISO 13485, MDSAP, and MDR.
• 7+ years' experience of working in a Quality Assurance, GMP manufacturing or Medical Device role.
• Extensive knowledge of cGMPs with a broad understanding of scientific principles associated with product development.
• Extensive experience in the packaging design and development of combination products including prefilled syringes, autoinjectors, and pens.
• Experience interacting with FDA investigators and other regulatory agencies audits.
• Knowledge and application of root cause analysis methodology and device CAPA requirements
• Experience in change management (pre and post launch) of either medical devices or medical device combination products.
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues.
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement.
• ASQ CQE Certification or Six Sigma certification.
• ISO 13485 Lead Auditor Certification preferred.
• Thorough understanding and application of cGMP and the principles and concepts of relevant quality processes and systems.
• Thorough understanding and application of Country Specific Standards.

Nice-to-Have

• Familiarity with Packaging ISO, ISTA, AAMI and ASTM Regulations and other related areas including testing of sterile barrier systems, package integrity testing, and medical device packaging standards.
• Able to learn and apply established procedures in a reliable and consistent manner.
• Capable of working independently with minimal supervision.
• High level of attention to technical details and accuracy.
• Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
• Able to work collaboratively in cross functional teams.
• Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
• Proficiency in general computer software such as word processing, spreadsheets, presentations.
• Understand Good Manufacturing Practices (GMP).
• Strong leadership, negotiation, interpersonal, communication, and facilitation skills
• Comfortable working and making risk-based decisions, interpreting regulations, and explaining device quality system principles.
• Proven problem-solving skills.
• Ability to lead and deliver in a matrix environment.
• Experienced in the management of external vendors and suppliers.

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.
PHYSICAL/MENTAL REQUIREMENTS
Sitting, ability to travel, driving license.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
N/A
\nRelocation support available\n
Work Location Assignment: On Premise
The annual base salary for this position ranges from $131 200,00 to $218 600,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17,5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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