Quality Product Manager

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Essential Duties and Responsibilities:

Under the direction of the Director of Quality Assurance, ensure end-to-end product quality for designated products.  This encompasses all aspects associated with manufacturing and testing of designated product(s) components (antibody, payload and linker), drug substance and drug product.  Provide Quality oversight to ensure manufacturing and testing is conducted in compliance with all applicable filings, regulations and cGMPs. Serve as the primary Quality representative and product quality expert for designated product(s) in relevant forums including CMC teams and Supplier Relationship Teams.

• Acquire and maintain end-to-end product knowledge enabling a contextual understanding of designated product(s) from development through current day.
• Partner with relevant teams to highlight potential quality issues during development, manufacturing and testing and identify/execute strategies to effectively manage them.
• Collaborate with key CMC stakeholders on development of the overall control strategy (e.g., in-process, release, stability testing and respective acceptance criteria (i.e., limits)).  Approve the sampling and test plan that defines the testing requirements at each manufacturing step.
• Participate in Stability Review Committee and Specification Review Board meetings. Review/Approve product specifications. 
• When establishing a new CMO or CTL, serve as a member of the assessment team to determine if the prospective supplier has the necessary and sufficient quality system capabilities to ensure product quality.
• Review and approve process validation protocols and reports, as well as master batch records for use by CMO and partners.
• Assist in the disposition all batches of antibody, payload, linker, drug substance and drug product. 
• Review and approve all relevant change controls, deviations, investigations and associated CAPAs.
• Lead complaint investigations and recalls, as necessary.
• In partnership with SMEs from Technical Operations , review trended product data (as prescribed by the designated product(s) monitoring plans) and assess impact of process changes and effectiveness of CAPAs and change controls on product quality.
• Monitor compliance to respective Quality Agreements and escalate issues to respective Supplier Relationship Manager and senior management, when necessary.
• Lead the risk management process for designated product(s).  This includes the conduct of quarterly risk assessment reviews, creation of a relevant risk reduction plan, track progress of actions to mitigate risk and justify acceptance of residual risk.  Partner with other Quality Product Steward(s) to assess risk at the CMO/CTL level.
• Coordinate development of Annual Product Reviews and FDA metrics for designated product(s) and ensure completeness including lifecycle management commitments.

Education and/or Work Experience Requirements:

• Education:

BS/MS in relevant scientific or engineering discipline.

Experience:

• Minimum of 8 years of relevant experience in the pharmaceutical industry, including time spent in a Quality role in a GMP environment.
• Working knowledge of batch release processes and associated accountabilities (assessment of batch data, deviations, investigations, change controls, complaints, etc.).
• Preferable to have experience in both small molecules and biologics, as well as involvement in process development of ADCs.

• Preferable to have experience working with third party manufacturers.

• Additional professional requirements and behavioral competencies:

• Knowledge of cGMP and regulatory requirements for ADC manufacturing and testing.
• Demonstrated effectiveness in partnership relationships in the areas of communication, influence and negotiation.
• Demonstrated effectiveness in problem solving, decision making and managing a diverse set of activities across multiple stakeholders.
• Ability to travel, as required, to support partner execution.

Personal Characteristics:

• Results Oriented:  Establishes clear goals and expectations and effectively allocates resources.  Consistently delivers.  Has flexible and creative problem solving skills. 
• Strategic Thinker: Is able to see the big picture and understand the challenging and sometimes conflicting needs within an organization.  Thinks logically, develops and evaluates options, and identifies pros and cons.  Constantly strives for ways to add value and improve how work is done. 
• Team Leader: Able to manage, lead, and nurture talent.  Encourages team to present and debate their best ideas and holds the team accountable for results.
• Communications:  Strong, clear communicator who recognizes that new ideas and approaches require a great deal of communication.  Able to communicate across functions and bring people together around a common goal. 
• Self-directed: Able to work effectively with limited direction in a complex, fast-paced environment.
• Positive Energy: Brings energy into the room and is a strong collaborator. 
• Innovation:  Drives and supports new ways of thinking and embraces change.
• Patient Focus:  Work with urgency and go the extra mile.  The patient is waiting.

Physical Requirements:

• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

• Must be able to lift and carry up to 10 lbs
• Must be able to talk, listen and speak clearly on telephone

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html