Site QA Operations Lead

Pfizer • Sanford, NC

3d • Onsite

About The Position

The Site QA Operations Lead is responsible for operational management and leadership of the QA Operations teams in support of manufacture, testing and release of Monoclonal Antibody (mAb) and Vaccines in the growing site product portfolio. The QA Operations Lead will be responsible for the combined QA operations supporting the timely start-up of Monoclonal Antibody manufacture as well as the established commercial products at this growing site. The primary role of the site QA Ops lead is to ensure manufacture and testing is conducted in compliance with current PQS, GMP and regulatory requirements as well assuring the optimal organization of QA Ops resources to support timely delivery of QA Ops commitments. What You Will Achieve The site QA Lead is accountable for the quality and compliance throughout the product lifecycle ensuring that all dispositioned materials, components, in-process and final drug substance and drug products comply established specifications and meet their license requirements and current GMPs in all markets that the products are distributed to. This position will be a member of the site Quality Operations Leadership Team (QOLT) and will report to the Site Quality Operations Leader (SQOL). The incumbent is also responsible for working closely with SBO DS Cluster, Pfizer Global Supply (PGS), Worldwide Research and Development (WRD) and Global Regulatory Affairs (GRA) teams to develop strategies on new product introduction for ADC Monoclonal Antibodies and Vaccines. This role will support the wider Pfizer network with quality, compliance, and technical support as required. How You Will Achieve Organizes and manages the team to comply with the requirements of the Quality Unit, as outlined in GMP’s (e.g., 21 CFR 211.22 ; Eudralex Volume 4 Part 1 Chapter 2). Ensures optimal organization and management of QA Ops resources to support timely batch release, deviation handling, testing, validation and registration activities. Responsible for championing the overall site investigation system (manufacturing and laboratory investigations) and ensuring the effective operation of the site investigations in adherence to the site and global SOP requirement. Oversees and assures overall quality and compliance of all products manufactured and distributed in worldwide markets. Establishes and maintains oversight on quality issues in manufacturing and laboratory processes. Ensures the source and specifications of starting materials used in the batch are compliant with the MA. Notifies and liaises with other Sr Quality Leaders in the organization to ensure aligned direction and response to specific quality issues and complaints at the site. Ensures timely reporting of significant quality issues or complaints to regulatory agencies, according to local legislation (e.g., FAR and BPDR for US marketed products, other BOHs as applicable). Ensures compliance and effectiveness of Quality Processes supporting manufacture and release. Accountable for staffing, training & development, coaching, of the team. Ensure the team is sufficiently agile, flexible and supportive of current and future growth of the site. Be available to their direct reports for real time escalations of any concerns or support as needed. Contribute to promoting a ‘Right First Time’ and ‘Continuous Improvement culture’ with quality and wider teams. Represent QA at product, technical and robustness team meetings and lead/drive all associated support activities. Ensure QA teams upskill and continue to develop knowledge required to support batch disposition. Liaise between the team and all customers both internal and external. Support Operations teams with investigations and resolution of discrepancies, providing consultative support on quality related issues to manufacturing operations. Lead cross-functional teams as required where strategic leadership is needed. Represent and support the team to ensure BSC site metrics are met. Ensure issues are escalated as appropriate to SQOL, and that feedback is sought in a timely manner. Perform and assist with additional duties as may be directed by the SQOL.

Requirements

• BA/BS with 8+ years of experience or MBA/MS with 7+ years of experience.
• Previous relevant Quality and management experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company.
• Excellent communication and interpersonal skills.
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Demonstrated ability to positively influence colleagues at all levels within an organization.
• Demonstrated ability to work independently as well as a member of a team in a dynamic, fast-paced environment.
• 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.
• Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
• Primarily standard 1st Shift work hours with some exceptions to meet business needs.
• Some travel will be required to support network and sister site initiatives; ~10% required travel.
• This position requires permanent work authorization in the United States.

Responsibilities

• Organizes and manages the team to comply with the requirements of the Quality Unit, as outlined in GMP’s (e.g., 21 CFR 211.22 ; Eudralex Volume 4 Part 1 Chapter 2).
• Ensures optimal organization and management of QA Ops resources to support timely batch release, deviation handling, testing, validation and registration activities.
• Responsible for championing the overall site investigation system (manufacturing and laboratory investigations) and ensuring the effective operation of the site investigations in adherence to the site and global SOP requirement.
• Oversees and assures overall quality and compliance of all products manufactured and distributed in worldwide markets.
• Establishes and maintains oversight on quality issues in manufacturing and laboratory processes.
• Ensures the source and specifications of starting materials used in the batch are compliant with the MA.
• Notifies and liaises with other Sr Quality Leaders in the organization to ensure aligned direction and response to specific quality issues and complaints at the site.
• Ensures timely reporting of significant quality issues or complaints to regulatory agencies, according to local legislation (e.g., FAR and BPDR for US marketed products, other BOHs as applicable).
• Ensures compliance and effectiveness of Quality Processes supporting manufacture and release.
• Accountable for staffing, training & development, coaching, of the team.
• Ensure the team is sufficiently agile, flexible and supportive of current and future growth of the site.
• Be available to their direct reports for real time escalations of any concerns or support as needed.
• Contribute to promoting a ‘Right First Time’ and ‘Continuous Improvement culture’ with quality and wider teams.
• Represent QA at product, technical and robustness team meetings and lead/drive all associated support activities.
• Ensure QA teams upskill and continue to develop knowledge required to support batch disposition.
• Liaise between the team and all customers both internal and external.
• Support Operations teams with investigations and resolution of discrepancies, providing consultative support on quality related issues to manufacturing operations.
• Lead cross-functional teams as required where strategic leadership is needed.
• Represent and support the team to ensure BSC site metrics are met.
• Ensure issues are escalated as appropriate to SQOL, and that feedback is sought in a timely manner.
• Perform and assist with additional duties as may be directed by the SQOL.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level