New · posted Nov 11
Johnson & Johnson · Pharmaceuticals
Senior Manager, External Quality Business Processes and Strategic Projects
- Horsham, PA
- On-site
- Full-time
- Manager
The role
The Senior Manager, Business Processes is accountable for driving the improvement of External Quality (EQ) business processes and for leading strategic projects that ensure their compliant and efficient execution.
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
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 of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Belgium R-110332, Ireland R-110334, Italy R-110335, Switzerland R-110333, United States of America R-108589
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
We are searching for the best talent as Senior Manager, External Quality Business Processes and Strategic Projects.
What you need
- University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering) required; Master’s degree preferred.
- 10+ years of combined experience in Quality Assurance, Quality Control, Validation or Engineering in the pharmaceutical industry is required. Broad understanding of the quality organization (e.g., quality operations, quality systems) preferred.
- Working knowledge of quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review required.
- Proven knowledge of applicable Data Integrity regulations required.
- Working experience in an FDA/EMA GMP-regulated pharmaceutical environment and familiarity with ISO requirements preferred.
- Proven project management skills and experience, including knowledge of project methodologies and process excellence, required. Six Sigma and/or Lean certification preferred, or willingness to obtain it.
- Budget management experience preferred.
- Quality mindset and ability to enable Critical and Design Thinking, with a risk-based approach that gives full consideration to patient safety and quality.
- Strong problem-solving and conflict-resolution skills; able to analyze complex problems under pressure, reach valid conclusions and deliver solutions, acting independently and knowing when to involve others.
- Results-oriented, with a strong track record of delivering on objectives; sense of urgency and ability to zoom in and zoom out.
- Strong leadership and facilitation skills; able to build productive partnerships and to influence and negotiate effectively at all levels, including without line authority, to drive harmonization.
- Experience working in a matrix organization and collaborating across functions in a local and global context, including with remote teams, while managing complexity.
- Strong communication (verbal, written and presentation) and interpersonal skills, self-awareness and adaptability required.
- Passion for sharing knowledge and facilitating the learning of others.
- Demonstrated ability to rapidly learn, evaluate, and adopt new AI tools and ways of working to meet evolving business needs.
- This position may require 10% of domestic and/or international travel.
Johnson & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Preferred Skillsnice to have
AI Judgement Integration, Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Cross-Functional Collaboration, Data Savvy, Fact-Based Decision Making, ISO 9001, Leverages Information, Mentorship, Organizing, Process Governance, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility
What you'll do
- Establishes a Process Excellence/Lean culture within EQ, using existing methodologies (e.g. Lean, Value Stream Mapping) to identify and deliver improvements.
- Owns and executes the Root Cause Problem Solving process to investigate and solve issues systematically.
- Facilitates complex investigations using advanced techniques (e.g., Kepner-Tregoe) and applies statistical analysis to various data sets.
- Acts as single point of contact (SPOC) for EQ Data Integrity/Governance: design and implementation of the EQ Data Integrity/Governance framework, together with a Data Integrity/Governance team representing each platform, supports the Site Quality Heads in the risk-based definition and execution of the plan and drives sustainable Data Integrity/Governance gap remediation, reuse of solutions and continuous improvement across the platforms.
- Ensures a sustainable knowledge management framework across the platforms, including initial train-the-trainer sessions on Data Integrity/Governance.
- Acts as EQ SPOC and SME for TransCend and Batch Release Hub. Represents EQ by providing quality perspectives, requirements and compliance standards, and acts as Change Champion across EQ to support global standardization, process harmonization and S/4 HANA adoption.
- Ensures cross-functional alignment, assesses business risks and develops mitigation strategies. Ensures any asks of EQ are understood and appropriately and timely resourced.
- Actively manages the P&O project portfolio.
- Defines and collects KPIs to support platform metrics and QMR (specific projects).
- Owns the communication and change management framework across the platforms (specific projects)
- Owns the submission and support of FARs and BPDRs to the FDA.
- Acts as back-up for the EQ budget process.
- Responsible for any other projects that may arise over time.
- Maintains compliance with all company policies and procedures.
Where you'll work
Horsham, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in Horsham, PAWorking conditions
Job Function
Quality
Job Sub Function
Business Process Quality
Job Category
Professional
All Job Posting Locations
Horsham, Pennsylvania, United States of America
From the posting
About Johnson & Johnson
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Manager roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $142,000 | $154,500 | $166,750 |
Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 96 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- GMP and compliance5
- Documentation and SOPs4
- Investigations and CAPA3
- Quality systems and risk3
- Data and digital systems3
- Lab testing and methods2
- Validation and qualification2
- Regulatory submissions2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirementsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 18
- Locations
By discipline
- Quality25 60%
- Clinical9 21%
- Regulatory8 19%
By level
- Manager16 38%
- Senior & Principal15 36%
- Associate & Specialist7 17%
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Senior Manager, External Quality Business Processes and Strategic Projects at Johnson & Johnson
Applications close November 18.