Associate QA Operations Director - Systems and Process

About the role

The Associate QA Operations Director – Systems and Process is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.). They partner with the organization to successfully, thoroughly, and timely execute complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). They work closely with QA and cross-functionally with Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) as needed to identify, mitigate, escalate, and resolve issues and risks.

Responsibilities

• Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management.
• Provide guidance on Quality systems usage, process requirements, best practices and record completeness.
• Provide QA oversight of Veeva periodic enhancements (quarterly and annually).
• Provide cross-functional guidance on deviations, change requests, CAPA, effectiveness checks and associated actions, supporting complete, thorough and timely completion of the quality records.
• Track and trend supported systems, provide metrics for Quality Systems Management Review (QSMR).
• Execute clinical and commercial artwork and labelling review and approval, including oversight of vendors; resolve quality issues.
• Manage conflict by engaging teams to address issues, seeking diverse views and facilitating identification of options to achieve an equitable solution.
• Drive results and influences others outside of direct authority.
• Manage objective setting and balances commitments to prioritize and complete activities within established timelines.

Qualifications

• BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience;
• or, MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience;
• or, Equivalent combination of education and experience.

Skills & Abilities

• Apply wide range of knowledge of biotechnology/pharmaceutical sector to perform complex work, provides input beyond the QA function and proposes solutions to highly complex issues.
• Demonstrate strong time-management and organizational ability to analyze and improve processes and consistently produce high quality work.
• Excellent written, verbal and presentation communication skills, able to translate and communicate complex concepts across all levels of the organization.
• Proven ability to manage multiple competing priorities, evaluate data to detect weak signals, blind spots and rapidly escalate cumulative risks.
• Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve a goal, and drive for results.