Commercial Quality Project Manager

Johnson & Johnson is currently recruiting for a Commercial Quality Project Manager! This position can be located in Shepherdsville, KY or Somerset, NJ with a preference for Kentucky.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more athttps://www.jnj.com/.

Position Summary:

The position leads and participate in projects impacting the US Pharm Distribution Centers (DCs). Provides project leadership and support related to quality systems for US Pharm CQ and US Deliver related initiatives, including but not limited to, Deliver Operations project support (e.g. CIPs, Quality lead for JJOS, etc.), DC related temp control projects and investigations (validation/qualification of temp control systems, mapping, etc.), site repack/relabel programs, end to end Q&C process improvements, compliance remediation, New Product Introduction and facility infrastructure changes.

Key Responsibilities:

Projects (50%) Provides project leadership and support related to quality systems for US Pharm CQ and US Deliver related initiatives, as needed, including but not limited to: Deliver Operations project support (e.g. CIPs, Quality lead for JJOS, etc.), DC related temp control projects and investigations (validation/qualification of temp control systems, mapping, etc.), site repack/relabel programs, special inspection protocols, end to end Q&C process improvements, compliance remediation, New Product Integration

Quality System Execution (25%) Responsible for supporting revisions/reviews related to local DC level procedures overseeing; periodic review monitoring; training audience identification in collaboration with the DLM team; providing technical and process support to DC personnel for the quality system applications including but not limited to DMS, LMS, QEM and Change Control systems; and participating in change control, quality investigations, and CAPA development as appropriate.

Compliance (25%) Executes activities to sustain compliance within the region including participating in and supporting the DC related internal audit program, management of notified body audits (i.e. management of notified body audits, as applicable), external audit support (DEA, TSA, FDA), JJRC audits and supplier audits. Additionally, coordinating required updates to the Approved Supplier List, performing gap/impact assessments for enterprise and cross segment, and global pharm procedural changes as they relate to DC Operations.

Other: Executes compliance activities on behalf of leadership including, but not limited to; the creation and revisions of regional and local procedures and/or work instructions • Escalates all appropriate issues to management. • Makes quality decisions based upon assessments of compliance risks balanced with the overall business needs. • Drives strategic initiatives for both the Franklin Distribution Center (FDC) and the Kentucky Distribution Center (KDC). Ensure such strategies are driven through to closure timely and compliantly.

QUALIFICATIONS

Education:

A minimum of a Bachelor or equivalent University degree is required with a focus in Engineering, Scientific, Business, or Quality Regulatory Compliance preferred.

Experience and Skills:

Required:

• 6-8 years experience in Medical Device, Pharmaceutical, or Consumer products industry.
• Work experience in a highly regulated industry and a solid understanding of FDA 21 CFR Part 210, 211, ISO 9001 and/or ISO 13485
• Proven experience leading projects and influencing team members to achieve results without direct supervision
• Strong written and verbal communication skills, the ability to take initiative independently as well as collaborate as part of a team
• Proven problem solving, decision-making, data analysis, inductive reasoning, critical thinking and root cause analysis skills
• Excellent communication and presentation skills.
• Strong change management, collaboration and influencing skills to partner effectively across functions.
• Ability to work under tight timelines and be customer focused and oriented.
• Must be able to manage/provide leadership to multiple sites
• Advanced proficiency with PowerPoint and Microsoft Excel (including VLOOKUPS and pivot tables)
• Demonstrated flexibility to handle complexity and multiple initiatives
• Proven ability to successfully partner and collaborate with business partners outside Quality
• Installation Qualification, Operational Qualification, Process Qualification (IQ, OQ, PQ) and associated report writing required.
• Experience interpreting compliance requirements and regulations.
• Experience with Temperature Control.

Other:

• This position may require up to 20% domestic travel.
• This role may act as delegate for Sr. Manager, NA Commercial Quality
• The anticipated base pay range for this position is 100000 to 172500.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• 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)).
• 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 of Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below.https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.”

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

Summary

• Job titleCommercial Quality Project Manager
• FunctionQuality
• Sub functionCustomer/Commercial Quality
• CategoryManager, Customer/Commercial Quality (P7)
• LocationShepherdsville, Kentucky, United States; Somerset, New Jersey, United States
• Date postedDec 09 2024
• Requisition number2406225973W