Overview
Life Sciences Consultant, Process & Procedures Lead (Pharma/Biotech) — this role supports a global Life Sciences client in strengthening its procedural framework amid international growth and evolving regulatory demands. The consultant leads cross-functional discussions to assess, design, and optimize procedural documentation (SOPs/WIs) to support operational efficiency and inspection readiness.
Company overview: Business Integration Partners (BIP) is a Europe-based digital consulting company expanding its footprint in the United States, with practices in Life Sciences, Financial Services, Energy, Retail, Data & AI, Cybersecurity, Risk & Compliance, Change Management, and Digital Transformation.
Responsibilities
- Assess the impact of procedural updates or changes on the existing process and procedural landscape.
- Identify and engage SMEs, stakeholders, and business leaders for content development, review, and approval to ensure cross-functional alignment and compliance.
- Lead process mapping sessions, capturing scope, boundaries, inputs, outputs, steps, sequences, and visual representations.
- Facilitate process discussions to align scope, resolve discrepancies, and drive consensus on procedural updates, process improvements, and content standards.
- Translate cross-functional activities into procedural documentation and process maps.
- Author procedural documentation in a clear, concise, and compliant manner aligned to internal Content Standards.
- Maintain project schedules, proactively identify risks, and escalate with recommendations to ensure timely delivery.
- Address procedural gaps related to deviations, inspection commitments, and CAPAs to ensure compliance and on-time project completion.
- Collaborate with Quality Managers to ensure content aligns with internal Content Standards and Lean Writing Principles.
- Manage document workflows within the Document Management System, including review and approval cycles.
- Coordinate document approvals with business stakeholders and SMEs to ensure timely and compliant finalization.
Qualifications
- Minimum 5–10 years in an external client-facing role as a Consultant or similar experience.
- 3–5 years of experience documenting and updating business processes and procedures, with a focus on authoring procedural documentation (SOPs, WIs) within the Global Pharma or Biotech industry.
- Document Management system experience, ideally in Veeva.
- Awareness of GxP regulatory 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 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.
Compensation and Benefits
The base salary range for this role is $110,000 - $160,000
- 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
BIP US is an equal opportunity employer. We provide a non-discriminatory environment and consider a wide range of qualifications including job-related abilities, without regard to age, gender, gender identity, sexual orientation, race, color, religion, national origin, disability, genetic information, veteran status, citizenship, or marital status.
BIP US provides a reasonable range of compensation for our roles. Actual compensation is influenced by factors including skill set, education, level of experience, and knowledge.
Seniority level
Employment type
Job function
- Project Management, Writing/Editing, and Analyst
- Industries: Business Consulting and Services, Health and Human Services, and Pharmaceutical Manufacturing
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