The Head of Compliance Oversight & Process Excellence ensures regulatory adherence in labeling & artwork operations, drives process improvements, and manages a team while collaborating with stakeholders.
JOB SUMMARY
The Compliance Oversight & Process Excellence (CO&PE) function enables the labeling & artwork organization to fulfill compliance duties and execute upon required quality management practices. The function is responsible for overseeing activities that ensure compliance with regulations & internal procedures, providing operational & process excellence support, and serving as the primary point of contact for inspections & audits.
Responsibilities include ensuring labeling & artwork policies and processes are efficient, comprehensive and meet regulatory requirements. Ensuring appropriate compliance & oversight plans and measures are in place for the labeling and packaging artwork domain. Ensuring that monitoring and analysis of performance and compliance metrics are robust and effective. And provides outcome reporting to various quality management and operational governance bodies.
The CO&PE Head, working closely with key stakeholders, is accountable for creating and implementing a framework of inspection and audit readiness within the labeling and artwork domain. This position helps others understand the subject matter and dependencies holistically such that opportunities for identifying trends, process gaps and corrective & preventive actions can be achieved. This position champions the design and execution of identified areas compliance and process improvements within the labeling and artwork domain.
This leadership role has accountability for the Compliance & Process function, managing a team of individual contributors with a focus on talent development, performance management, and retaining key talent. The CO&PE Head is accountable for creating an encouraging, supportive and highly productive work environment for immediate function as well as other GILA functions.
ROLE RESPONSIBILITIES
Manages and provides ongoing guidance & mentoring to Compliance & Process Leads to ensure staff can fulfill their job roles. Works with primary stakeholders to establish business priorities for mid-to-long term needs.
Ensures oversight of labeling, data quality and compliance by;
Supports all process and compliance initiatives and activities for labeling and artwork strategy & operations. Works with key stakeholders across GRS and the CMO by;
Works across GILA and GRS to align stakeholder business needs and expectations and ensure processes develop accordingly. Drive continuous improvement, efficiency and innovation efforts by:
QUALIFICATIONS / SKILLS
Education :
Experience:
Technical Skills
ORGANIZATIONAL RELATIONSHIPS
This role reports to the VP, Global & International Labeling and Artwork organization and manages compliance and process oversight activities. This role will interact with various stakeholders and colleagues within G&IPE, across GRS, across CMO and PRD as necessary.
RESOURCES MANAGED
This role manages a team of individual contributors which includes Pfizer staff and may include vendors and contractors.
Work Location Assignment: Hybrid / Onsite
The annual base salary for this position ranges from $204,700.00 to $341,100.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 22.5% 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.
* The annual base salary for this position in Tampa, FL ranges from $184,200.00 to $307,000.00.
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.
Regulatory Affairs
#LI-PFE
The Compliance Oversight & Process Excellence (CO&PE) function enables the labeling & artwork organization to fulfill compliance duties and execute upon required quality management practices. The function is responsible for overseeing activities that ensure compliance with regulations & internal procedures, providing operational & process excellence support, and serving as the primary point of contact for inspections & audits.
Responsibilities include ensuring labeling & artwork policies and processes are efficient, comprehensive and meet regulatory requirements. Ensuring appropriate compliance & oversight plans and measures are in place for the labeling and packaging artwork domain. Ensuring that monitoring and analysis of performance and compliance metrics are robust and effective. And provides outcome reporting to various quality management and operational governance bodies.
The CO&PE Head, working closely with key stakeholders, is accountable for creating and implementing a framework of inspection and audit readiness within the labeling and artwork domain. This position helps others understand the subject matter and dependencies holistically such that opportunities for identifying trends, process gaps and corrective & preventive actions can be achieved. This position champions the design and execution of identified areas compliance and process improvements within the labeling and artwork domain.
This leadership role has accountability for the Compliance & Process function, managing a team of individual contributors with a focus on talent development, performance management, and retaining key talent. The CO&PE Head is accountable for creating an encouraging, supportive and highly productive work environment for immediate function as well as other GILA functions.
ROLE RESPONSIBILITIES
Manages and provides ongoing guidance & mentoring to Compliance & Process Leads to ensure staff can fulfill their job roles. Works with primary stakeholders to establish business priorities for mid-to-long term needs.
Ensures oversight of labeling, data quality and compliance by;
- Maintaining the labeling and artwork quality management plan
- Ensuring routine process and quality monitoring and reporting outcomes according to business plan and schedule
- Supporting QE, CAPAs & audits/inspections
Supports all process and compliance initiatives and activities for labeling and artwork strategy & operations. Works with key stakeholders across GRS and the CMO by;
- Supporting Business Process Owners and ensuring delivery of core related responsibilities
- Championing policy/process development for current and future business processes
- Leading, managing or contributing to Labeling policies and processes via CMCDs, business cases, etc.
Works across GILA and GRS to align stakeholder business needs and expectations and ensure processes develop accordingly. Drive continuous improvement, efficiency and innovation efforts by:
- Using available data to analyze, identify trends and opportunities for improvement.
- Serving as a leader of CI projects aimed to increase efficiency, simplify, improve quality, and/or reduce costs.
- Keeping informed of industry norms and evaluate opportunities to improve Pfizer best practices.
QUALIFICATIONS / SKILLS
Education :
- Master's Degree or equivalent.
- Advanced academic qualification/degree desired but not required; equivalent relevant professional experience will be considered.
Experience:
- Min 10+ years' experience in global/multi-national pharmaceutical environment, including direct experience either in Labeling/Artwork or Regulatory Affairs role.
- Experience in Continuous Improvement required. CI training, e.g. RCA, Six Sigma, etc. desired.
- Experienced with audits and GCP/GVP inspections or other quality related background.
- Experience with interacting autonomously with senior leaders and working in a matrix team environment a must.
- Experience in interpreting and applying global/local regulatory guidance and associated supportive documentation desirable.
- Experience with managing a small, globally-located team of individual contributors. Including team-building and coaching/mentoring.
- Demonstrated track record of delivery to time and quality.
- 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.
Technical Skills
- Strong leadership and excellent and adaptable written/oral communication skills.
- Ability to transform ambiguous discussions into structured outcomes.
- Ability to synthesize and communicate complex data and information easily to a variety of audiences.
- Strong relationship building and partnering with a wide range of business stakeholders, crossing multiple divisions, countries, and cultures.
- Strong problem-solving capabilities, excellent facilitation and project management skills.
- Proven leadership at driving highly complex projects to meet evolving business needs.
- Mastery of tools & techniques related to planning and managing complex projects w/established deadlines.
ORGANIZATIONAL RELATIONSHIPS
This role reports to the VP, Global & International Labeling and Artwork organization and manages compliance and process oversight activities. This role will interact with various stakeholders and colleagues within G&IPE, across GRS, across CMO and PRD as necessary.
RESOURCES MANAGED
This role manages a team of individual contributors which includes Pfizer staff and may include vendors and contractors.
Work Location Assignment: Hybrid / Onsite
The annual base salary for this position ranges from $204,700.00 to $341,100.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 22.5% 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.
* The annual base salary for this position in Tampa, FL ranges from $184,200.00 to $307,000.00.
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.
Regulatory Affairs
#LI-PFE
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Global O2C Collections Analyst will manage customer collections, disputes, and account resolutions while ensuring timely reporting and compliance in a virtual team environment.
Top Skills:
ExcelMs PowerpointMs TeamsMs WordSap Erp
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Data Quality Lead will develop data quality practices, modernize data services, oversee cross-functional teams, and establish analytics capabilities in a digital environment.
Top Skills:
AIJavaMachine LearningPythonRSASScalaSnowflakeSparkSQLTableau
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead epidemiological studies on pneumococcal vaccines, design studies, author reports, collaborate across teams, interpret data, and provide subject matter expertise.
Top Skills:
Data AnalysisEpidemiological MethodsObservational StudiesStatistical MethodsVaccines
What you need to know about the Pune Tech Scene
Once a far-out concept, AI is now a tangible force reshaping industries and economies worldwide. While its adoption will automate some roles, AI has created more jobs than it has displaced, with an expected 97 million new roles to be created in the coming years. This is especially true in cities like Pune, which is emerging as a hub for companies eager to leverage this technology to develop solutions that simplify and improve lives in sectors such as education, healthcare, finance, e-commerce and more.
