Senior Manager, Quality Assurance Operations

The Senior Manager of Quality Assurance Operations manages the quality operations activities for Puma and assures overall compliance of clinical and commercial manufacturing and global distribution activities.

The Sr. Manager will have oversight of all quality aspects relating to drug substance, drug product, and/or finished product manufacturing, testing, labeling, packaging, and distribution. This position will oversee lot release operations and work performed by Puma's Contract Manufacturing Organizations (CMO), contract laboratories, and/or Commercial Business Partners ensuring timely delivery of quality products and services throughout the Global Supply Chain.  

The Sr. Manager will also support the implementation and management the quality systems activities for clinical and commercial operations and assure overall compliance of clinical and commercial activities.  

Major Duties/Responsibilities

§  Serve as Quality Operations representative  on core Puma projects related to Chemistry, Manufacturing, and Controls (CMC), overseeing all QA operational compliance activities including requirements of Global Commercial Partnerships, as required

§  Provide oversight of Puma CMOs and Partners associated with commercial drug substance, drug product, and/or finished product manufacturing and distribution

§  Prepare the required documentation to disposition Drug Substance, Drug Product, and/or Finished Product as required

§  Ensure appropriate quality systems are in place to support product release in a compliant and timely manner, and routinely monitor performance in effort to optimize turnaround

§  Ensure compliance to Global Regulatory Requirements as they relate to CMC and Quality. 

§  Ensure Global Labeling is compliant with Regulatory requirements and product characteristics

§  Prepare written quality impact assessments related to product quality issues with Clinical Trial Materials and Commercial Products

§  Organize, facilitate, and attend cross-functional meetings as the QA representative and Quality Subject Matter Expert (SME), as required

§  Manage and evaluate changes associated with products. Ensure that CMOs and/or Partners have up to date records related to product quality and are informed of any changes or issues that may impact the product in their region 

§  Support preparation and participate in regulatory inspections at Puma, CMOs and/or Partner sites. Ensure Puma’s CMOs are inspection ready for any of the regions where Puma’s products are distributed

§  Support Puma’s Internal Audit Program as required.  

§  Actively interface with and provide support to Global Supply Chain group to develop processes, meet compliance requirements, and develop Good Distribution Practices in all regions

§  Approve specifications, Master Batch Records, analytical methods, technical reports, protocols, and SOPs to ensure compliance with cGMP and Puma internal procedures

§  Perform quality review of manufacturing documents, including executed batch records, deviations, investigations, complaints, changes, validation, and technology transfer documents from Puma’s CMOs and/or Partners.

§  Relay product impacting quality issues such as, manufacturing changes, non-conformances, and product complaint systems to internal and external stakeholders.

§  Assist in any recall activities of Puma products, including recalls in territories managed by Puma’s Partners.

§  Assist in obtaining information from CMOs and/or Partners for Puma’s Annual Product Review (APR) and provide APR Report to Partners as required.

§  Ensure GXP records follow appropriate Good Documentation Practices, including appropriate version control, and are archived appropriately.

Skills & Abilities

§  Thorough understanding of regulatory compliance requirements with the ability to provide applicable guidance to team members

§  Previous experience with analytical testing, test methods, and method validation.

§  Team player attitude with experience contributing to multi-disciplinary project teams and be able to work with minimal supervision

§  Outstanding written and verbal skills as well as problem solving skills 

§  Strong initiative and ability to assume significant project management roles

§  Ability to work in a fast-paced, dynamic environment 

§  Ability to travel domestically and internationally

§  Strong communication skills with ability to work in cross-functional teams on assigned projects

§  Self-motivated and able to prioritize projects in with short lead times

Supervisor Responsibilities

§  This is an individual contributor role, but may require supervision of direct reports depending on the needs of the QA department

Work Environment

§  This job operates in a professional office environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

Physical Demands

§  The physical demands of the office are normally associated with extended amounts of time in front of a computer.  While performing the duties of this job, the employee is frequently required to stand, walk, and sit.

§  Requires travel, both domestic and international, typically 20% or more as business needs dictate.

Position Type/Expected Hours of Work

§  This is a full-time position.  Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m., but may be adjusted to accommodate work with CMOs and Commercial Partners in other time zones.  This position may require working long hours and weekend work.

Education & Professional Experience

Education

§  B.S. degree in a scientific discipline

Experience

§  8-12 years of QA experience working in quality operations in the pharmaceutical or biotechnology industry, with specific experience in GXP quality assurance auditing and GXP regulations, or combined experience working in Quality control and/or Manufacturing

§  Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GXP and ICH guidelines

§  Complete and thorough understanding of regulatory compliance  requirements for US FDA, European Union, and Health Canada

§  Prior experience with Health Authority Audits

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice.

Equal Opportunity Employer
Puma Biotechnology Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.