Head, Compliance Oversight & Process Excellence
Head, Compliance Oversight & Process Excellence
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$ 184200 - 307000
1 Vacancy
Job Description
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;
- 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:
- Masters 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
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.
Employment Type
Full-Time
