Senior Manager Medical Devices and Combination Products Quality Operations

Use Your Power for Purpose

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

This position is part of Pfizers Medical Device and Combination Products (MDCP) Quality Operations team. As Sr. Manager of Medical Device Quality Assurance Development you will be responsible for ensuring that product development teams comply with design control and regulatory standards (21 CFR 820 ISO 13485 ISO 14971) throughout the entire product lifecycle. The role supports the delivery of the Medical Device and Combination Products development portfolio in collaboration with the Pfizer Pharmaceutical Sciences Organization. You will work closely with cross-functional teams to establish innovative methodologies facilitate agreements and rigorously review deliverables to guarantee product safety compliance and efficacy. Your specialized knowledge will contribute to achieving team goals within Pfizers quality system necessitating exceptional communication analytical and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues communicate across all organizational levels prioritize quality assist in completing critical deliverables clarify complex matters and foster effective teamwork.

How You Will Achieve It

Oversees and ensures compliance with SOPs quality standards (e.g. 21 CFR 820 ISO 13485 IEC 62366 IEC 62304 ISO 14971) and regulatory requirements including conducting audits identifying areas for improvement and implementing corrective actions.

Routinely provides guidance and interpretation of SOPs and standards within PharmSci and with external partners.

Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls risk management quality management systems change controls vendor management and complaints.

Monitor changes to global regulations and ensure policies and procedures reflect applicable changes implements quality system best practices and communicates company-wide policies on quality system effectively.

Identifies leads development of and participates in implementation of new processes / programs for quality improvement initiatives with the MDCP space.

Proactively seeks global alignment / interpretation in application of policy / procedure.

MDCP Quality Assurance oversight of facility utilities equipment computer system validations and change controls. Support Management Review & Quality Councils as required.

Has technical and quality knowledge on later phase product life cycle strategies (e.g. design verification design validation process validation ICH stability etc.). Leads and advises as needed.

Expert in quality investigation techniques and leads complex quality investigations and develops QA decisions. Actively contributes to PSQRT / AQRT.

Creates develops and delivers training courses; performs review of training effectiveness identifies trends and develops actions to remediate compliance issues as required.

Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions.

Recognized as a coach mentor and technical expert; participates as an external influencer at conferences or standard committees.

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelors degree with at least 6 years of experience; OR a masters degree with at least 5 years of experience; OR a PhD with 1 years of experience

Thorough understanding and application of one of the following : 1) cGMP and current good manufacturing practices in a pharmaceutical environment 2) 21 CFR 820 Rule 21 CFR 4 current good manufacturing requirements for Combination Products or 3) medical devices and / or combination products including ISO 13485 & ISO 14971

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

Strong leadership negotiation interpersonal communication and facilitation skills

Strong analytical and computer skills are required.

Bonus Points If You Have (Preferred Requirements)

The combination of strong pharmaceutical and / or medical device development experience preferred

Thorough understanding and application of cGMP specifically 21 CFR 820 Rule 21 CFR 4 current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems

Extensive experience in risk management and design control of medical devices combination products from concept through launch or pharmaceutical manufacturing operations in a GMP environment

Proven ability to succeed in a fast-paced challenging and complex environment

Proven ability to mentor engineers

Experience interacting with FDA investigators and other regulatory agencies.

Knowledge and application of device 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.

ISO 13485 Lead Auditor Certification

Non-Standard Work Schedule Travel or Environment Requirements

The role may include frequent business travel across Pharmaceutical Sciences vendors and suppliers.

Other Job Details

Work Location Assignment : Hybrid - On premise 2-3 days per week at a Europe US Latam Central America Pfizer location

Work Location Assignment : Hybrid

The annual base salary for this position ranges from $120800.00 to $201400.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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 providers 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.

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Quality Assurance and Control

Required Experience :

Senior Manager

Key Skills

Employee Evaluation,Continuous Improvement,FDA Regulations,Management Experience,Process Improvement,Profit & Loss,Operations Management,Project Management,Strategic Planning,Leadership Experience,P&L Management,Supervising Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 120800 - 201400