Facilities Compliance Specialist

Facilities Compliance Specialist

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 .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases.

Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area.

We are currently exploring three gene therapy modalities : gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas.

We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

For more information, please visit our website : www.astellasgenetherapies.com.

The Role :

As part of the Engineering & Facilities team, the Compliance Specialist Biopharma Facilities and Engineering is responsible for delivering compliant methods, systems, and documentation in support of engineering and facilities services.

The role will implement, and upgrade systems used to manage facilities, lab, and process assets. This includes their maintenance, calibration, spare parts, drawings, and turnover packages.

The incumbent will ensure the asset lifecycle management (ALM) procedures and administration support to facilities teams and contractors is effective and compliant.

They will participate in quality and regulatory initiatives to ensure compliance with applicable regulations, standards, and corporate policies, while also overseeing work conducted by project teams to guarantee it is compliant with internal and external policies and procedures.

Responsibilities :

• Administer the Quality Management processes for the Engineering & Facilities team (change control, investigations, discrepancies, CAPA’s), filing of records, updating applicable quality management systems, and maintaining relevant metrics as assigned.
• Lead facilities and systems continuous audit readiness initiatives through period walk throughs and assessments with area owners, capturing deficiencies for remediations, and tracking assignments, resolutions, and relevant metrics;

participate in audit readiness, facilitation, and response activities for the department and site teams.

• Establish and manage internal controls for the asset lifecycle management program, including processes for verification of incoming parts used for repair and replacement that require drawing, specification, material certification, or performance verifications.
• Support the sustained compliance of departmental training curriculums, facility self-assessments, drawing and documentation controls, personnel and vendor / supplier audits and qualification file maintenance, site programs relating to regulatory or statutory compliance, and maintaining relevant metrics.
• Provide direction and training to vendors, facilities personnel, and service providers as required to ensure that Quality Assurance expectations are communicated and followed.
• Supply direction, procedures, and training to the systems user community including team members, vendors, and service providers ensuring feedback channels are open and collaborative, and the visibility of systems tools and tips is maintained.
• Track and trend systems activities on a periodic basis, providing compliance metrics for Management Reviews
• Create maintenance plans and assist with defining maintenance processes, driving improvements, and achieving KPI targets;

Lead change initiatives and continuous improvement efforts such as Lean Six Sigma / 5S.

• Evaluate opportunities to maximize asset life by leverage predictive and conditioned based maintenance plans (i.e., vibration analysis, water loop chemistry, thermography, motor performance).
• Support breakdown investigations and process improvement changes to maximize asset performance.
• Facilitate the addition of new assets in accordance with asset lifecycle management procedures and workflow with visibility via dashboards, status reports, & meeting minutes.

Quantitative Dimensions :

The Compliance Specialist Biopharma Facilities and Engineering is accountable for delivering methods, systems, and documentation that are compliant with applicable regulations, standards, and corporate policies.

Their role will ensure work that is conducted conforms with internal and external policies and procedures.

Organizational Context :

The Compliance Specialist Biopharma Facilities and Engineering will typically report to the Manager, Facilities, and Engineering.

This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create;

operates with transparency; is trusted; and supports the overall mission and vision of the Astellas organization.