Quality Product Manager
vor 2 Monaten
**Company Description**
**Job Description** 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.
**Qualifications** 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 limi
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