Seagen

Senior Manager Quality, Country Affiliates

Description

Position Summary:

The Senior Quality manager has a dual role in supporting GMP/GDP activities and also PV activities in Canada. This role will oversee and put in action Country Affiliate quality management system for GMP/GDP/PV and make sure the organization meets its compliance obligations connected to an establishment license for its specific business model and supports the Global QA Compliance team in carrying out compliance activities.

The Senior Manager will Act as a Local Safety Officer (LSO) and as a local nominated contact for PV (if relevant), which has a primary responsibility of ensuring that the local PV activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners. Having an appropriate system of PV and Risk Management in place to assure appropriate oversight for products within their responsibility.

Principal Responsibilities:

GMP/GDP

• To implement all quality and pharmaceutical aspects of the Canadian organization
• Continuously improve and maintain the Quality System to remain in compliance with the applicable GMP/GDP regulations and local requirements for Canadian affiliate
• Provide support to improvements of the Quality System documentation system to ensure the system remains current with focus on Corporate and Canadian procedures
• Participate in internal and external audit programs including follow-up activities (if applicable)
• Oversee and lead local regulatory or other inspections for country affiliates
• Actively manage CAPA plan implementation both from relevant audits and Inspections
• Single point of contact for all quality-related matters for Canadian affiliate
• Participate in or drive risk assessment, decision-making, communication and risk-reducing action related to defective product
• Manage annual product quality review and/or oversee management review for Canada when needed
• Manage the documentation GAP assessment process for Canadian affiliate
• QA review and release commercial and clinical products
• Set personal performance goals and provide input to departmental objectives
• Maintain and communicate work priorities to meet goals and timelines
• Complete all job-related training while striving to continuously improve on knowledge and skills in quality, compliance and technology

PV

• Collects, follows-up, and forwards spontaneous, literature and solicited AE cases according to global and local SOPs
• Ensures timely and appropriate submission of single cases to local Health Canada and Ethics Committees (as required)
• Performs local literature screening
• Ensures oversight of local vendors performing drug safety activities
• Assures compliance with global and local SOPs and WIs.
• Where relevant drafts and maintains local SOPs and Working instructions
• Assures adequate pharmacovigilance training of the local organization
• Acts as the point of contact for Health Canada for local interactions related to patient safety/ public health for the local market
• Creates and facilitates implementation of PV business continuity plans (e.g. inspection readiness, audits, and AE reporting coverage)
• Ensures awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluates the impact on local processes and informs the appropriate global and regional groups
• Acts as a local subject matter expert (SME) for risk management (RM). Leads local implementation of Risk Minimization measures, in compliance with RMPs
• Ensures local audit and inspection readiness at all times
• Performs root cause analysis of deviations relevant to the local PV processes
• Oversees the development, implementation, and execution of CAPA plans
• Ensures local implementation of PV/Safety Data Exchange Agreements and appropriate PV language and execution of local third-party agreements
• Maintains a close connection with the local organization including but not limited to Medical Affairs, Clinical and Participates in local projects, leadership meetings as appropriate
• Contributes to planning and preparation of Aggregate Reports to HA and EC (as required)

Qualifications:

• Actual knowledge of GMP and GDP and other applicable regulatory requirements
• In-depth knowledge and experience with quality systems, corrective action and preventative action system, statistical process control, risk management, FMEA, and other key tools for managing quality performance
• In depth knowledge of validation (analytical validation, computer validation, process validation)
• Must be capable of assessing compliance to quality requirements using sound judgment and decision-making skills
• Auditing experience
• Experience in working with regulatory inspection first hand will be preferable
• Subject matter expert in local, regional, and any other relevant legislation related to PV (e.g. EU, ICH)
• At least 5-7 years of relevant GMP/GDP experience and at least 3 years of PV experience in a pharmaceutical setting in Canada

Education:

• Bachelors or master’s degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 10/30/2020