Associate QA Director

Job Overview

About the role

Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level.

Responsibilities

• Plan, schedule, conduct, report and close audit activities, as assigned
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
• Aid in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
• Manage the quality assurance oversight of projects, assignments, training and staff
• Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
• Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Host customer audits and participate in review of corrective action plans, as assigned
• Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
• Oversee documentation, reporting, and closure of compliance issues
• Support Quality Management in proposal reviews and reporting QA metrics
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
• Participate in or lead (cross functional) teams for special projects as assigned
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements

Qualifications

• Bachelor's Degree
• Preferred 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience.
• Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures'
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation and leadership skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to manage multiple activities and timelines.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Skills

• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures'
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation and leadership skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to manage multiple activities and timelines.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Benefits

The potential base pay range for this role, when annualized, is $88,600.00 - $246,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Pay

The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Schedule

Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.