20.Director Biologics Pilot Plant Quality

, PA, United States

Location Exton, PA

**Job Summary**

This position ensures the Biologics Pilot Plant (BPP) operations and quality control functions comply with cGMP regulations (Japan, EU and US), Industry Standards and Company corporate quality expectations, and the companys *hhc* mission. This includes, but is not limited to; production, testing and disposition of Biological Drug Substance (BDS) or Antibody Drug Intermediate (ADI), raw materials and cell banks at

the BPP and at CMOs/CROs for clinical and commercial use. This position is also responsible for ensuring that the internal and external quality management system/processes will support cost effective provisions of BDS, ADI, raw materials and cell bank. The quality oversight responsibilities at the BPP include both development and commercial quality functions.

This position will be the key member of the BPP Commercialization Committee, to contribute to the strategic decisions and directions, and execute actions to establish site commercial quality systems and readiness.

This position will also lead the continued development, implementation, and maintenance of phase appropriate GxP quality management systems and compliance for biological products from pre-clinical through commercial launch as the Development Quality Assurance (DQA) team.

This position is responsible to select and manage CMO/CRO for BDSand ADI manufacturing and analysis from a quality perspective including auditing and ensuring PAI readiness.

The position will maintain collaborative working relationship and effective communication within DQA and internal customers, such as Pharmaceutical Science and Technology (PST), Company Demand Chain System (EDCS), Global Product Quality Headquarters (GPQ), Regulatory Affairs and external parties.

**Essential Functions**

Provide oversight and leadership to ensure that the quality of biologics for clinical and commercial use will comply with cGMP regulations (Japan, EU and US), Industry Standards and Company corporate quality expectations to ensure that the site is inspection ready.

Contribute to the strategic decisions and directions to establish readiness to manufacture and test biologics for commercial use as a delegate of the Quality organization. Execute actions as planned and assigned.

Direct management and teams to maintain QMS and/or continually evaluate current policies, procedures and practices to develop and implement continuous improvements in the BPP.

Other examples of responsibility :

* Provide quality oversight to internal/external organizations for the manufacture and analysis of BDS or ADI, raw materials, cell banks and critical

* Provide Quality support for the review and data verification of BLA/MAA/JNDA as well as auditing of the source

* Identify and report any critical quality incidents to DQA Head, Head of Americas Quality, and subsequently to Chief Quality Officer (CQO).

* Supervise people managers/individual contributors and provide guidance and leadership. Manage employee-related activities including performance management and development. Identify resource Participate in recruitment, and compensation planning for assigned employees.

* Serve as the Quality contact for the site with regards to interactions with regulatory agencies and business Leads regulatory inspections and partner audits.

* Serve as a delegate of the Quality organization for the BPP Commercialization Committee, a member of the Strategic Operations Meeting and lead the Quality Council Governance Committee. Attend Company Biopharmaceutical Council meetings as

* Develop department budget and ensure the department is committed to financial

* Develop/review/approve quality agreements, and/or SOPs associated with PQ and DQA

* In partnership with senior management, establish a quality culture and philosophy at the site which will guide the development of policies, practices, procedures, and standards by which all site operations are performed; provide quality assurance input to Company strategic

* Facilitate the setting of both short-term and long-term goals of the QA operations group and ensure accountability for achieving results

**Requirements**

* Bachelors degree in Biology, Chemistry, Engineering or related Masters degree, preferred

* Minimum 12 years of experience in a cGMP environment for pharmaceutical products, including minimum 5 years of experience working with biologic products in commercial manufacturing. Monoclonal antibody-based bulk drug substance experience strongly

* Minimum 5 years of leadership experience in a Quality

* Advanced knowledge and experience with biologics regulatory expectations for Quality Assurance, Quality Systems, QC and GMPs.

* Advanced knowledge of manufacturing and testing of

* Experience in facilitating and supporting regulatory audits (FDA, EMEA, PMDA, ) in support of pre-approval and general inspections.

* Technical and scientific

* Excellent problem solving and decision making

* Self -motivated individual comfortable working with detailed information and

* Excellent organizational skills

* This position is expected to be physically present at the site (not a remote role)

* Excellent verbal/written communication and interpersonal

* Strong presentation

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