Associate Director Business Engagement

• A minimum of a Bachelor's degree (BS/BA) or equivalent 4-year degree is required, preferably with a focused degree in science, engineering, organizational manager or other related field.
• A minimum of 8 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment.
• Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
• Strong understanding and experience with process remediation.
• Strong understanding of product / process development principles, including regulatory filing / approval processes across all segments of the business, product types and regions.
• Experience in performing GxP audits, including the development of risk-based audit strategies, audit planning, conducting audits and reporting audit outcomes in a concise manner.
• Strong problem-solving skills, negotiating skills, influencing skills, and developing relationships.
• Excellent written and oral communication & Financial acumen.
• Strong decision making and analysis skills and interpersonal skills, including ability to communicate with individuals and groups at all levels.
• Demonstrated ability to leverage data analytics tools and platforms to develop compliance insights, real-time reporting dashboards, and audit program performance metrics.
• Demonstrated capability to drive digital process innovation and automation, including the identification and adoption of artificial intelligence tools in a compliance or audit context.

Enterprise Compliance (ERC / JJIA)

The ERC (JJIA) audit team, working with Innovative Medicines quality and compliance stakeholders and the J&J supply chain.

• Eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k))
• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year; Colorado – 48 hours per calendar year; Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year