Job Description
Job Description
Job Summary -
Strides Pharma Inc. is seeking a highly organized and experienced Site Investigation Lead to manage our cross-functional investigation team at our Chestnut Ridge, NY site. This role is responsible for leading and overseeing the timely, thorough, and compliant execution of manufacturing and laboratory investigations, including root cause analysis, corrective and preventive actions (CAPA), and documentation practices. The Site Investigation Lead will supervise both Quality Control (QC) and Manufacturing Investigators to drive continuous improvement and ensure compliance with cGMP and regulatory standards.
Key Accountabilities & Responsibilities
Investigation Management
- Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.
- Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.
- Review and ensure Investigation order is proper and logical.
- Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.
- Review and ensure Identification of CAPA’s is consistent with investigation findings
- Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.
- Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.
- Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.
- Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,
- Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.
- Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.
- Review and identify areas of improvement in the investigations.
- Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.
Workload Management
- Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations
- Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.
Staff Development
- Evaluate potential candidates for Invstigation team; performance evaluation of direct reports.
Education & Experience
- Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or related scientific discipline (Master’s preferred)
- 10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management
- Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events
- Working knowledge of FDA, EU, and other global regulatory requirementsDemonstrated management and leadership experience with strong interpersonal and influencing skills.
Knowledge
- In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles
- Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms
- Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)
- Experience with Quality Management Systems (e.g., TrackWise, MasterControl)
Skills & Abilities
- Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.
- Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.
- Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
- Demonstrated flexibility in carrying out varied assignments in a high quality work environment.
- Excellent written and oral communications skills with a strong emphasis on organizational capabilities.
- Excellent analytical thinking and problem-solving skills
- Excellent critical thinking and root cause analysis skills
- Ability to work cross-functionally and influence without authority
- Proven ability to meet deadlines while handling multiple investigations
Physical Requirements
- Ability to work on-site full-time in both office and GMP environments
- Sit or stand for extended periods; walk between manufacturing and laboratory areas
- Ability to occasionally lift or move materials up to 25 pounds
- Use of personal protective equipment (PPE) as required