Manager, Analytical Quality Assurance

Site Investigation Lead, Quality Assurance

Lead Quality Specialist - Investigator

Responsibilities: Accountability AQA Management <ul><li>Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines.</li><li>Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation.</li><li>Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting.</li><li>Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails.</li><li>Collaborate with QC, QA, and R&amp;D departments to support method validations, transfers, and investigations.</li><li>Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries.</li><li>Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents.</li><li>Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise.</li><li>Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness.</li><li>Mentor, coach, and develop the AQA team to build a high-performing quality organization.</li></ul> Workload Management <ul><li>Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> SOPs <ul><li>Review/Approve SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li></ul> Staff Development <ul><li>Evaluate potential candidates for QA, performance evaluation of direct reports.</li><li>Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing.</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field (master’s or Ph.D. preferred).</li><li>Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control.</li><li>Proven leadership or supervisory experience in a GMP-regulated environment.</li><li>Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills..</li></ul> Knowledge <ul><li>Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia.</li><li>Knowledge of pharmaceutical manufacturing processes and laboratory practices.</li><li>Familiarity with regulatory submission requirements (ANDA, NDA, etc.).</li><li>Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise).</li></ul> Skills &amp; Abilities <ul><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>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.</li><li>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.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills.</li><li>Strong attention to detail with a commitment to quality and compliance.</li><li>Effective leadership, team management, and interpersonal communication.</li><li>Ability to prioritize and manage multiple tasks in a fast-paced environment.</li><li>Proficient in technical writing and reviewing complex data and reports.</li></ul> Physical Requirements <ul><li>Ability to sit or stand for extended periods.</li><li>Occasionally lift up to 25 pounds.</li><li>Use of personal protective equipment (PPE) as required in laboratory or production areas.</li><li>Ability to work in office, laboratory, and manufacturing settings as needed.</li><li>The work environment is representative of a group laboratory environment.</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>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.</li><li>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.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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Manager, Analytical Quality Assurance

Site Investigation Lead, Quality Assurance

Lead Quality Specialist - Investigator

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Lead Quality Specialist - Investigator

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