Senior Process & Procedures Consultant (GCP / Clinical Development)

BIP US; New Jersey; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Remote/hybrid work environment support

401k matching

PTO 20 days

Discretionary bonus

Employee assistance program

Job summary

BIP US is seeking a seasoned Process & Procedures Lead to strengthen procedural frameworks for a global Life Sciences client. You will translate complex processes into clear SOPs/WIs, engage SMEs and leaders across functions, and drive compliance, efficiency, and inspection readiness.

This high-impact role requires 5–10 years in pharma, strong writing and project management skills, and the ability to lead cross-functional initiatives in a dynamic global environment.

Qualifications

• 5–10 years in an external client-facing Consultant role or equivalent.
• 5–10 years documenting and updating business processes and procedures (SOPs/WIs) in Global Pharma/Biotech.
• Experience with a Document Management system, ideally Veeva.
• Knowledge of GCP regulations and compliance requirements.
• Industry experience in Global Pharma/Biotech.
• Ability to discuss complex information with diverse stakeholders.
• Experience in controlled procedural document principles and process improvements.
• Ability to translate complex processes into lean, clear processes.
• Strong leadership, organizational and project management skills.
• Bachelor’s degree; MBA or advanced degree preferred.

Responsibilities

• Lead cross-functional conversations with SMEs and business leaders globally to design and optimize SOPs/WIs.
• Assess impact of procedural updates on existing processes and ensure alignment with compliance.
• Identify stakeholders for content development, reviews, and approvals; manage timelines.
• Map processes with scope, boundaries, inputs, outputs, steps, sequences, and visuals.
• Author clear, compliant procedural documentation per internal standards.
• Maintain project schedules, identify risks, and escalate with mitigation plans.
• Address procedural gaps related to deviations, CAPAs, and inspection readiness.
• Collaborate with Quality Managers to align content with Lean Writing Principles.
• Coordinate document workflows and approvals within DMS and with business stakeholders.

Skills

Client-facing experience

Process documentation

Project leadership

GCP knowledge

Document management (Veeva)

Pharma/Biotech domain

Cross-functional collaboration

Bachelor's degree

MBA preferred

Education

Bachelor's degree in engineering or business

MBA or advanced degree preferred

Tools

Veeva

Job description

Business Integration Partners (BIP) is Europe’s fastest growing digital consulting company and are on track to reach the Top 20 by 2030, with an expanding global footprint in the US (New York, Philadelphia, Boston, Charlotte, Chicago, Houston). Operating at the intersection of business and technology we design, develop, and deliver sustainable solutions at pace and scale creating greater value for our customers, employees, shareholders, and society.

BIP specializes in high-impact consulting services across multiple industries with 6,000 employees worldwide. Our industry domains include Life Sciences, Financial Services, Energy, and Retail, supplemented with Data & AI, Cybersecurity, Risk & Compliance, Change Management and Digital Transformation practices. We integrate deep industry expertise with business, technology, and quantitative disciplines to deliver high-impact results for our clients.

BIP is currently expanding its footprint in the United States, focusing on growing its Life Sciences business within global pharmaceuticals and biotechnology. Our teams operate at the intersection of business strategy, technology, and data to help our clients in driving smarter decisions, reducing risks, and staying ahead in a fast-evolving market environment.

Specific Opportunity:

We are seeking a seasoned Process & Procedures Lead to support a global Life Sciences client in strengthening its procedural framework amid rapid international growth and evolving regulatory demands. This role sits at the intersection of compliance, operational excellence, and stakeholder engagement.

The Consultant will lead strategic conversations with SMEs and business leaders across global functions to assess, design, and optimize procedural documentation (i.e., SOPs/WIs). This is a high-impact role requiring cross-functional collaboration, the ability to translate complex business processes into clear, compliant documentation that supports both operational efficiency and inspection readiness.

The consultant will manage and lead projects for the development of procedural documents for global development by:

• Assessing the impact of procedural updates or changes on the existing process and procedural landscape.
• Identifying and engaging SMEs, Stakeholders and Business Leaders required for content development, review, and approval to ensure cross-functional alignment and compliance.
• Leading process mapping sessions, capturing key process elements including scope, boundaries, inputs, outputs, steps, sequences, and visual representations.
• Facilitating process discussions to align scope, obtain perspectives, resolve discrepancies, and drive consensus on procedural updates, process improvements and content standards.
• Translating cross-functional activities into procedural documentation and process maps.
• Authoring of procedural documentation in a clear, concise, and compliant manner that aligns to internal content standards.
• Maintaining project schedules, proactively identifying risks or issues, and escalating with recommendations as needed to ensure timely delivery.
• Addressing procedural gaps related to deviations, inspection commitments, and CAPAs to ensure compliance and on time project completion.
• Collaborating with Quality Managers to ensure content aligns with internal Content Standards and Lean Writing Principles.
• Managing document workflows within the Document Management System, including review and approval cycles.
• Coordinating document approvals with business stakeholders and SMEs to ensure timely and compliant finalization.

Requirements:

• Minimum 5-10 years in an external client facing role as a Consultant or other relevant experience.
• 5-10 years of experience in documenting and updating business processes and procedures, with a strong focus on authoring procedural documentation (i.e., SOPs, WIs), within the Global Pharma or Biotech industry.
• Document Management system experience, ideally in Veeva.
• Knowledge of GCP (Good Clinical Practice) regulations and compliance requirements.
• Industry and/or consulting experience in Global Pharma or Biotech.
• Ability to understand and discuss complex information with people of diverse occupational backgrounds.
• Experience in controlled procedural document principles, process design and leading process improvements.
• Ability to understand and translate complex processes into lean processes.
• Strong leadership, organizational, and project management skills.
• Bachelor’s degree in engineering, business, or a related field. An MBA or advanced degree is preferred.
• Choice of medical, dental, vision insurance.
• Voluntary benefits.
• Short- and long-term disability.
• HSA and FSAs.
• Matching 401k.
• Discretionary performance bonus.
• Employee referral bonus.
• Employee assistance program.
• 11 public holidays.
• 20 days PTO.
• 7 Sick Days.
• PTO buy and sell program.
• Paid parental leave.
• Remote/hybrid work environment support.

For more information about BIP US, visit https://www.bip-group.com/en-us/.

It is BIP US Consulting policy to provide equal employment opportunities to all individuals based on job-related qualifications and ability to perform a job, without regard to age, gender, gender identity, sexual orientation, race, color, religion, creed, national origin, disability, genetic information, veteran status, citizenship, or marital status, and to maintain a non-discriminatory environment free from intimidation, harassment or bias based upon these grounds.

BIP US provides a reasonable range of compensation for our roles. Actual compensation is influenced by a wide array of factors including but not limited to skill set, education, level of experience, and knowledge.