Senior Manager Manufacturing (CMC) Quality Assurance

Aktis Oncology; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Aktis Oncology is seeking a Senior Manager for Manufacturing Quality Assurance in Boston. The role will lead QA functions in GMP manufacturing, ensuring compliance with regulations while mentoring staff. Candidates should have a strong background in quality assurance within a biopharmaceutical context, demonstrating leadership and expertise in aseptic processing.

Qualifications

• 4+ years of relevant work experience in Biologics or Drug product Manufacturing.
• Quality Assurance background with knowledge of GMP, FDA regulations.
• Ability to implement Quality Management System (QMS).

Responsibilities

• Lead Quality Assurance functions associated with GMP manufacturing and product release.
• Responsible for on-floor quality support and deviation investigations.
• Oversee product compliance with U.S. and EU cGMP regulations.

Skills

Quality operational experience

Leadership in Quality

Aseptic processing

Problem-solving

Education

BS/BA degree in scientific or allied health field

Job description

Senior Manager Manufacturing (CMC) Quality Assurance

Join to apply for the Senior Manager Manufacturing (CMC) Quality Assurance role at Aktis Oncology

Senior Manager Manufacturing (CMC) Quality Assurance

Join to apply for the Senior Manager Manufacturing (CMC) Quality Assurance role at Aktis Oncology

The Sr Manager, Manufacturing (CMC) Quality Assurance will be responsible for leadership of the various Quality Assurance (QA) functions associated with GMP manufacturing and product release, as well as individual contributions, to establish clinical manufacturing phase appropriate Manufacturing Quality Operations for Aktis. Quality Assurance for GMP product manufacture and release is comprised of many specific responsibilities as defined below:

• Responsible for “On Floor/In Process” Quality support to Manufacturing.
• Primary driver and overseer for manufacturing deviation investigations and product disposition decisions.
• Responsible for manufacturing batch record (MBR) review. Ensure review of batch data, including batch records, deviations, and other systematic controls as applicable to determine acceptability of final product disposition and product release.
• Provide product label review, assuring all product identification and supportive information is accurate, legible, and present on all units of final product specific to each global region is distribution.
• Drives Manufacturing Trend Analysis Management program associated with long-term manufacturing product quality. Holds period meetings to review recent results and long-term trend developments.
• Manage all product supply shipment non-conformance issues and associated investigations driving towards product quality impact and continued acceptability of use.
• Manage all product compliant investigations and resulting outcome, both with regards to specific batch of radiopharmaceutical product, as well as possible impact to all product batch manufacture, past and future.
• Manage product recall events both internally and externally initiated. Coordinate product return and collection/product reconciliation.
• Non-conformance/CAPA Management support. Review and approve non-conformance reports. Mentor investigators and approvers on the investigation process and technical writing.
• Ensure manufacturing site compliance with current U.S. and EU cGMP regulations and industry standards as defined by Aktis Quality System.
• Oversee product change control events, assuring proper consideration of potential impact to product quality and assuring process is executed per Aktis Change Control system, giving final approval to product change.
• Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction.
• Provide input for continuous improvement of company quality systems.
• Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.
• Oversee all Quality aspects of technology transfer of product manufacturing and control systems to external third-party contract or internal manufacturing site.
• Manage GMP responsibilities by third party contract manufacturing organizations, providing interface and oversight of third-party Quality organizations.
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
• Establish, educate, and enforce standard operating procedures required under GMP.
• Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Identify performance or compliance gaps and implement or propose solutions.
• Maintain a state of readiness for and participate in audits and inspections.
• Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical and commercial supply.

Knowledge, Skills, And Abilities

• Quality operational experience implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility.
• Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required.
• Demonstrated experience building and leading exceptional Product GMP Quality Assurance team.
• Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologic and Drug therapy products.
• Working knowledge of aseptic practices and clean room design/operations auditing techniques.
• Strong leadership skills with the ability to thrive in a high throughput environment.
• Ability to lead and manage projects/teams within corporate objectives and project timelines.

Preferred Experience and Skills:

• Biologic or drug product manufacturing and/or analytical testing.
• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment, or facilities management.
• Diverse experiences in a GMP environment including, but not limited to, batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
• The ability to identify, focus, and solve problems in a timely and efficient manner.
• Experience with quality audits and FDA regulatory inspections.
• Experience or working knowledge of R&D or clinical supply areas and processes.

Education And Experience

BS/BA degree in a scientific or allied health field with 4+ years of relevant work experience, or relevant comparable background in Biologics or Drug product Manufacturing. Radiopharmaceutical background/experience a plus.

• Quality Assurance background.
• Knowledge of GMP, FDA regulations, and compliance.
• Ability to help support implementation of Quality Management System (QMS).
• Exceptional verbal, written, interpersonal, organizational and project management skills.
• Excellent organizational and project management skills.
• Able to lead and mentor junior/senior staff and cross functional teams.

The position reports directly to the Vice President of Quality Assurance.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing and Quality Assurance

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