"Alerted.org

Head of Development Product Quality Assurance, AMR

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Head of Development Product QA (AMR) reports to the Head of Product QA and is a member of the Product QA Leadership Team. As a leader contributes to the creation and execution of QA mission, objectives and 3–5-year strategic plan, and also contributes to the effective translation and execution into annual functional operating plans such that QA strategic goals are achieved.

The purpose of this position is to direct and provide Quality Assurance leadership and oversight for all aspects of the development, allocation and management of staff, processes, systems and resources required for Development Product QA group for Clinical Trial Material (CTM) activities.

Responsible for the strategic partnerships and collaboration with leadership in the QA organization and across stakeholder departments in order to manage Development Product QA and will contribute the quality strategies and priorities for short- and long- term objectives for CMC Product QA to fulfil the regulatory requirements for GMP and compliance for global supply and distribution of CTM.

Responsible for GDP oversight, CTM Product Quality Issue handling, Contract Manufacturing Organization (CMO) QA management, support to Supplier Evaluation Program, manufacturing, testing, of products through development stages to support both regional and global batch supply to clinical studies. In addition to above, the incumbent will be responsible for oversight of local GMP organization to execute CTM QMS and GMP as appropriate.

Essential Job Responsibilities:

+ Leads the Development Product QA (AMR) function ensuring high quality and continuous supply of Astellas CTM products.

+ Contribute to the strategy for Product QA for achievement of QA mission, vision and strategic objectives.

+ Develop the strategy for the regional team and accountable to ensure execution and achievement of strategic goals.

+ Responsible for forging and maintaining strong collaborative relationships with colleagues in the QA organization, and key stakeholders, as well as for external stakeholders, including CMOs and external partner quality organizations producing CTM.

+ Contributes to global coordination and communication within internal and external stakeholders including CMOs, internal manufacturing plants and affiliates in order to maintain highest product quality standards, efficacy and patient safety.

+ Manages the Development Product QA (AMR) function and its people, through successful recruitment, performance management, development planning and retention of a high performing team. Effectively delegates responsibilities to achieve goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.

+ Provides leadership, coordination, support, and guidance to ensure a comprehensive Quality System that complies with applicable regulatory requirements. Acts as advisor and partners with key stakeholders on key quality matters pertaining to CTM and CMO QA oversight.

+ Collaborates with equivalent Teams in other regions to drive consistent and efficient processes.

+ The Head of DPQA, AMR executes QA Activities taking direction where required from Chief Quality Officer, Head of CMC Product QA and Head of Product QA, Group Leads.

+ As part of the Quality Management System, maintains quality metrics, trends and escalates business risk to the Head of Product QA to implement continuous quality improvement.

+ Manage and ensure execution of key CTM QA activities under development stage as follows:

+ Contribute to any types of development projects and execute CTM QA activities under development stage

+ Provide technical input into CTM release for clinical studies

+ Prepare and coordinate specific technical QA guideline/SOP and/or policy documents under development stages

+ CTM Product Master File review and approval for global supply

+ CTM batch document review and QA release for clinical study

+ Implement risk management activities

+ Audit for supplier, vendor, or contractors for CTM

+ Shelf-life management of CTM

+ Evaluation for business partners such as new GMP service providers (including Due Diligence)

+ Change Evaluation and Control of CTM

+ Complaint Handling Management of CTM

+ GMP/GDP Deviation Management of CTM

+ Establishment of QA Agreements

+ Remains current with external regulatory compliance expectations, including reflection into DPQA capabilities to support QA management review; Preparation and review for performance data of GMP activities for CTM.

+ Execution of local GMP organization for CTM

+ Collaboration with other internal QA groups, including but not limited to Astellas Plants

+ Regulatory Inspection management

+ Partners with key stakeholders driving proactive identification of risk, compliance issues and opportunities for improvement as well as implementation of improvement initiatives.

+ Recognizes and assesses quality risks and ensures identified risks are evaluated and managed appropriately in order to accomplish business goals, regulatory and quality requirements. Escalates quality risks to the Head of Product QA where global oversight is warranted.

+ Manages the Significant Quality Issue process associated with CTM product manufactured or released in the AMR region to determine impact, scope and escalate appropriately.

+ Chairs the Risk Evaluation Committee, responsible for evaluation of Drug Product risk, assigning appropriate risk mitigation actions and determining if market action is appropriate. Escalates recall decisions in accordance with procedures and processes.

Qualifications

Required:

+ Minimum BSc in a science related field, with 8-10+ years of broad pharmaceutical industry experience related to CMC, GMP, QC and/or QA.

+ 2+yrs direct people management experience.

+ Experience working in the QA field is required,

+ Extensive knowledge of GMPs and other relevant regulations for CTM, as required, with an understanding of quality principles and industry trends.

+ Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work with internal and with external stakeholders.

+ GMP auditing experience of broad range of modality (including Biologics and Chemicals) and manufacturing steps (Drug Substances, Drug Products, and Packaging/Labeling) required.

+ Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.

+ Ability to apply industry knowledge and interpretation to anticipate impact of changes, issues and strategies necessary to facilitate open discussion.

+ Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities

+ Ability to direct multiple areas of responsibility with limited oversight. Demonstrated experience in developing /executing quality strategies with a pragmatic approach to decision-making.

+ Demonstrated competency in budget management and strategic planning.

+ Proven ability to influence diverse senior stakeholders.

Preferred:

+ Experience in a leadership role is preferred

+ Direct experience in Manufacturing Operations.

+ In-depth knowledge of global industry standards and regulatory requirements (e.g., US, EU and Japan).

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Referral bonus program

\#LI-TR1

Category CMC Product QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans