Associate QA Operations Director - Labeling & Systems

SUMMARY/JOB PURPOSE

The Associate QA Operations Director – Labeling & Systems is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). Partners 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. This role supports development, generation, review, and approval of clinical and commercial artwork and labeling. Demonstrates a high level of independent quality judgment and acumen.

ESSENTIAL DUTIES/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).

• Provide monthly Veeva Quality event status reports to QA and functional areas, proactively driving timely record closure.

• Execute clinical and commercial artwork and labelling review and approval, including oversight of vendors; resolve quality issues. Deliver on company core objectives in a timely manner, per supply plan, and drive for results.

• Lead process and system improvement.

• Responsible for generating a risk-based strategy across the GxP landscape to identify and manage issues and risks while driving continuous improvement, to ensure compliance with global regulatory standards and align with key stakeholders.

• Resolve quality issues, identify and mitigate risk, propose options and solutions, and escalate.

• SME for Health Authority inspections and audits.

• Establish and maintain strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues.

• Foster collaboration within QA and stakeholders, to gain mutual trust, achieve alignment and solve problems.

• 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

• Performs other duties as assigned

• Complies with all policies and standards

SUPERVISORY RESPONSIBILITIES

• No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES

Education

• 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.

Experience

• Experience in pharmaceutical or biotech industries, and packaging/labeling is preferred.

• Experience in development of business strategies, metrics, and continuous improvements is preferred.

• Proven indirect organizational and management skills, ability to manage complex issues, sound decision making and strategic skills.

• Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and manufacturing processes.

• International/global regulatory requirements experience preferred.

• Experience with participation in regulatory inspections and audits, presenting or defending functions.

Knowledge, Skills and Abilities

Required:

• 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.

• Understands technical information related