Senior Director, PQM Strategy Deployment & Excellence (USA)

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 at https : / / www.jnj.com

Job Function : Quality

Job Sub

Function :

Business Process Quality

Job Category : People Leader

All Job Posting Locations :

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description :

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

Belgium (Beerse) Req # : R-047934

USA (Raritan, Titusville) Req # : R-046243

Switzerland (Schaffhausen) Req # : R-047927

Italy (Latina) Req # : R-047934

We may also consider qualified internal candidates located in other Innovative Medicine manufacturing sites.

POSITION SUMMARY

The Senior Director PQM Strategy Deployment & Excellence is part of the Product Quality Management organization and will drive Product Quality (PQ) Excellence leadership, He / she is responsible for the development, deployment and execution of the strategy and roadmap for Product Quality Management & alignment with the major business partners in Innovative Medicine (IM) Supply Chain, IM Quality and DPDS. The individual also provides functional management to PQM Stability CoE, Risk Management and PQM Support, Central Product Complaint Investigation and PQM Digital Excellence

The Senior Director PQM Strategy Deployment and Excellence is a member of the PQM Leadership Team.

KEY RESPONSIBILITIES

Under the direction of the Vice President, Product Quality Management, provide Product Quality Excellence leadership to PQM and global initiatives across IM Quality and Supply Chain.

Owns the development and deployment of the PQM Strategy, ensure alignment of the Strategy and execution with IM Quality and other key PQM business partners such as Value Chain Management, Discovery Product Development and Supply (DPDS), Clinical Supply Chain and Small Molecule / BioTherapeutics development teams and within the IM Quality verticals,

Owns the PQM elements for IM Quality

Owns PQM Stability Program Management CoE.

Ensure compliance with all regulatory and IM and JNJ requirements while maximizing efficiency.

Lead IM Stability Program Management (SPM) cross functional team to ensure IM SPM strategy is established and updated, SPM performance measures are in place and continuously improving through effective cross functional team collaboration.

Owns Quality system elements including but not limited to the Quality Management review process, internal audit, documentation management, training, etc. within PQM to ensure compliance and continuous improvements.

Direct Product Risk Management activities within IM to ensure compliance with regulatory requirements. Ensure the successful application of Product Risk Management tools such as Criticality analysis, Product Risk Analysis (PRA) / Product Risk Management (PRM), FMEA, etc. within IM.

Leads the initiative to develop and promote more data driven and innovative approaches within the PQM team. Supports PQM through better product analytics, dashboards and continuous improvement projects. Holds accountabilities for all activities performed within the PQM organization.

Act as a representative for PQM at IM Quality and other global digital forums and initiatives.

Responsible for core PQM business processes such as PQM LRFP, Budget, Cascade, etc. Together with the team identifies, quantifies and drives improvement opportunities within PQM.

Build organizational capability and ensure his / her group effectively executing JnJ's performance management and talent development processes; having adequate resources and expertise to perform their duties related to product quality. Plan and manage the groups budgets.

Remains current in knowledge, skills and industry trends. Contributes to the strategy setting of the entire PQM organization. Train in new regulations, guidelines, procedures and processes. Make a positive contribution by making suggestions for improvement.

Deliver portfolio of projects including product or therapeutic area projects flawlessly using proven project management tools.

QUALIFICATIONS

A Bachelor's degree in Pharmaceuticals, Chemistry, Engineering, Sciences or similar

An advanced degree and / or Business (MBA, MS or PhD) is preferred.

At least 15 years of senior level experience in Biotech / Pharmaceutical Medical Device / Industry and broad scientific expertise, having demonstrable experience in leading complex global programs and improvement initiatives, projects and groups of professionals are required. Multifunctional background preferred.

A minimum of 7 years of people management & talent development experience is required.

Must have strong leadership skills and operate as a leader with global mindset, understanding and appreciation of the global / enterprise context.

Relationship management, excellent coaching and collaboration skills are required.

Must be an analytical and strategic thinker with the ability to create integrated sector wide solutions to align with sector and enterprise requirements.

Influence, shaping solutions, negotiation and consultative skills are required.

Must be a thought leader experienced in shaping solutions, with strong communication and collaboration / partnership skills.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills : Preferred Skills :

Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Consulting, Developing Others, Fact-Based Decision Making, Inclusive Leadership, ISO 9001, Leadership, Leading Change, Managerial Courage, Process Governance, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Six Sigma, Standard Operating Procedure (SOP), Tactical Thinking

The anticipated base pay range for this position is :

178,000 - 307,050 Additional Description for Pay Transparency :

Subject to the terms of their respective plans, employees and / or eligible dependents are 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.

Subject to the terms of their respective plans, employees are 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.

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits :

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of 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

Condolence Leave - 30 days for an immediate family member : 5 days for an extended family member

Caregiver Leave - 10 days

Volunteer Leave - 4 days

Military Spouse Time-Off - 80 hours

Additional information can be found through the link below.

https : / / www.careers.jnj.com / employee-benefits]]>