Senior Specialist EQ Small Molecules

• Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.
• Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Support the escalation and issue management processes.
• Review and approve quality systems documentation, including batch documentation and product disposition, change controls, manufacturing instructions, quality agreements, specifications, validation documentation, and technical studies.
• Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
• Build relationships with internal and external partners to meet patient supply requirements.
• Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions.
• Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.
• Provide quality oversight for tech transfer and new product introduction activities. Support a variety of projects both internally and with external manufacturers.
• Act as a backup to External Quality account owners in support of external manufacturers as needed.

• A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.

• A minimum of 5 years working in a cGMP regulated environment.
• Experience supporting quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation.
• Ability to work independently in support of a portfolio of products and external manufactures.
• Experience working on cross-functional project teams.
• Strong communication and influencing skills; demonstrates an ability to communicate at all levels of the organization.

• Experience working with external partners.
• Experience with product transfer, new product introduction, medical devices, and combination products.
• Proficient in applying process excellence tools and methodologies.

• This role may require up to 10% of domestic & international travel.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson