Artwork & Labelling Implementation Management Europe Cluster Lead

ROLE SUMMARY

This role is a first-line Manager level, which supervises and prioritizes the day-to- day work of internal and external resources who perform the ‘Market Coordinator’ role in Pfizer’s Enterprise Artwork & Labeling Management System (ePALMS) for processing Pfizer Artwork Requests (PARs) in an “above country” hub model. It also specifically involves oversight of activities associated with shared packaging across markets.

Serves as the primary, central ALIM Point of Contact (POC) for all activities and questions related to assigned cluster(s) of Markets and EU Centralised Procedure products. Assures Pfizer’s Biopharmaceutical portfolio complies with Regulatory and Commercial quality standards and Pfizer Trade Dress across assigned clusters of Markets.

Monitors changes to relevant national Artwork regulations and will advise and/or consult with Global Regulatory Affairs (GRA), Pfizer Global Supply (PGS) and Plant/Artwork Center (AWC) colleagues as needed to assure local and/or regional processes and documents (1) meet ongoing standards of quality, (2) adhere to Regulatory Compliance requirements and (3) will stand up to audit/inspection scrutiny.

Accountable for assuring staff compliance with monitoring “aging PARs” and that Market colleagues in Pfizer Country Offices (PCO) have transparency to status of final local printed labeling, which meets local Regulatory definitions of “Implementation”.

Accountable for compliance with global systems/processes used in Artwork development and change management as well as enforcing the use of these technologies/tools (e.g. ePALMS, PfLEET) to assure quality and integrity of information implemented into final Local printed labeling is maintained. As such, this role also acts as a business Subject Matter Expert (SME) on Artwork standards and system requirements.

Meets with internal auditors or external Regulatory agencies as needed to respond to inspections and/or queries regarding Labeling & Packaging Artwork operational processes and compliance for markets specifically under their remit and/or oversight.

This role reports to the ALIM European regional lead.

ROLE RESPONSIBILITIES

People Management:

• Oversees colleague Performance Appraisals, Individual Development Plans (IDPs), colleague engagement, salary administration, as well as new colleague hiring, training curriculum and staff development.
• Monitors workflows and sets priorities for direct reports to assure that labeling & packaging artwork timelines are met for new product submissions and commercialization across the Biopharmaceutical portfolio for designated Markets
• Provides appropriate direction to staff through leadership by example, coaching and mentoring as needed
• Prepares others to assume new or increased responsibilities by creating meaningful assignments, providing appropriate assistance, training, and succession planning.
• Works with other colleagues/leaders in the European ALIM team to ensure alignment in best practice, optimal use of resourcing, consistent approaches and assisting available internal and cross-functional projects.
• Represents team on Area Quality Review Team (AQRT) meetings; investigates and documents root cause analyses; takes a leadership role in addressing findings that impact team; makes recommendation on action plans and future risk mitigation strategies.
• Represents team on Supply Chain/Demand Management issues and negotiates with PGS in partnership with Regulatory colleagues in local PCOs if/as needed to prevent drug shortages.
• Ensures team is 100% inspection ready and provides leadership and direction for internal audits and/or inspections by Regulatory agencies.
• Interacts with members of cross-functional Quality teams to convey Regulatory Packaging and Labeling requirements - develops strategies to meet team goals of improving accuracy and/or Implementation speed.
• Consults with GRA to evaluate changes in regulations and guidance documents for impact on marketed products and takes action as needed to assure business continuity and ongoing compliance of Packaging Components
• Assists team in the development and maintenanceof Labeling & Packaging Artwork across multiple disciplines and cross-functional stakeholders in support of New Product introductions
• Partners with GRA PCOs and PGS AWCs to ensure accurate and timely progression of workflows; follows up as needed to assure PCO transparency into “Artwork Implementation” for revised labeling & packaging component Artwork as define by local regulatory agencies under the guidance of local market PCOs
• Relays Regulatory issues and concerns to PGS AWCs and/or PCOs as appropriate.
• Serves as primary adjudicator for team when complex Packaging Artwork decisions must be determined.
• Participates in development and maintenance of best working practices and/or SOPs to align development of Label Packaging Component Artwork between GRA, PCO, and PGS AWCs.
• Fosters strong relationships with ALIM team’s customers (Regulatory, PGS, Supply Chain, Demand Management, PCOs, Commercial and Legal) via regular communications and presentations, as needed.
• May evaluate and implement new Artwork technologies in close partnership with common stakeholders (e.g. PGS AWCs, Artwork Reviewers/Approvers, Business Technology groups and/or others in GRA organization.
• Monitors metrics related to progress of ALIM workload at regular intervals (e.g., project status, Artwork approvals, and Implementation metrics/timeliness) to assure appropriate transparency for all stakeholders on metrics and/or aging workflows; proactively makes recommendations for system enhancements and/or process improvements to assure efficiencies and/or appropriate quality controls are applied to Artwork & Labeling Implementation processes.

Note: In addition to operational oversight of direct reports, colleagues in this role will also periodically step in and perform the same day-to-day activities, depending on workload and capacity within their team

QUALIFICATIONS

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.

Education and Experience:

• Bachelor’s degree in an appropriate discipline, and strong related experience. An advanced degree is strongly preferred.
• Previous experience in either direct supervision of staff or complex matrix leadership role (e.g. strategic or cross-functional project team management) is required
• Previous international work experience either in a direct contributor role or in a supervisory capacity is required
• Must be familiar with cGMPs and have strong understanding of Labeling and artwork controls.
• Solid knowledge of regulations as they relate to all aspects of finished goods labeling, as well as import/export requirements, for relevant markets.
• Ability to see the big picture, lead cross-functional teams, influence strategic initiatives, drive process improvements and/or system enhancements related to end-to-end Labeling & Artwork operations.
• Ability to think flexibly, solve problems, prioritize projects, meet deadlines, and work under pressure.
• Ability to exhibit sound judgment and deal with ambiguity and change
• Strong interpersonal, organization and presentation skills required.

Demonstrated experience interfacing with key partner lines across GRA and technical teams (e.g. IM and Digital) as well as exposure to multiple tools used for managing and tracking end-to-end labeling and artwork workflows such as:

• eDocument Management systems (e.g. ePALMS, GDMS)
• Quality Review/Proofing systems (e.g. Docu-Proof, TVT)
• Systems used for tracking and oversight of labeling and artwork as well as tools used in the areas Packaging Engineering, Supply Chain Management, and Quality Operations (e.g. PDM, GRS, PfLEET, COSMOS, ERP)

Demonstrated understanding of broad end-to-end systems & processes is highly desirable, and candidates with direct previous experience in multiple areas are encouraged to apply:

• Labeling content development/maintenance
• Artwork development/maintenance and Change Controls associated with Implementation of Secondary Packaging Components
• Artwork creation and graphic design
• Manufacturing, Supply Chain management or Packaging Engineering

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Domestic and International travel is required

Work Location Assignment: Hybrid

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.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

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.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Regulatory Affairs