Site Investigation Lead, Quality Assurance

Mgr II Qlty & Reliability Engineering

Quality Manager

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>

Responsibilities: <ul><li>Manages plant quality staff across quality systems and product quality.</li><li>Oversees the quality and documentation system and quality records program.</li><li>Manages QMS processes for management review, CAPA, regulatory agencies, customer and internal audits.</li><li>Manages and provides resources for new product development, quality engineering, inspection, measurement,and test, complaint handling, non-conforming product and MRB resolution.</li><li>Ensures compliance to FDA QSR, ISO, MDD and other applicable requirements.</li><li>Site Management Representative for the TEM quality system.</li><li>Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis,statistical methods and process controls.</li><li>Provides sales and marketing support in explaining quality system and regulatory compliance capability tocustomers.</li><li>Contributes with the strategic Site team effort to accomplish results as needed</li><li>Provides leadership in the continuing evolution, improvement, and efficiency of the quality function.</li><li>Develops quality personnel to assure continuity and personal growth.</li><li>Understands and complies with all company rules and regulations.</li><li>Builds a Safe and Inclusive environment</li></ul> Requirements: Qualification &amp; Experience: <ul><li>10 years or more in a quality function with 5 years or more in management position.</li><li>BS/BA degree with a scientific/engineering emphasis required.</li><li>Leadership skills</li><li>Technical discipline or quality professional training.</li><li>Statistical techniques, metrology, and process analysis training.</li><li>Quality system design and implementation experience.</li><li>Lead and supportive on external audits.</li><li>Risk management .</li><li>Regulatory requirements and reporting responsibilities.</li><li>Supply chain development and management.</li><li>Strong analytical skills and attention to detail.</li><li>Excellent interpersonal and written communication skills.</li><li>Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decision and solveproblems independently.</li><li>A thorough knowledge of 21 CFR and ISO 13485.</li><li>Commitment to ethical conduct and responsibility.</li><li>Experience with MS Word, Excel, Project Management and Analytics software</li></ul>

Key Responsibilities: <ul><li>Develop, document, implement, and manage the Quality Management System (QMS) for the sub-business unit.</li><li>Foster a Zero Defect Culture and deploy continuous improvement initiatives to enhance operational performance.</li><li>Utilize structured problem-solving techniques to identify root causes and implement corrective actions.</li><li>Serve as a Our client Operating Advantage Champion, driving quality improvement initiatives.</li><li>Implement and refine 1ADM/1CP Quality initiatives, ensuring consistency and efficiency across enterprise-wide procedures.</li><li>Interface with key customers to address concerns related to product and process quality.</li><li>Arrange for QC inspections of incoming and outgoing products and establish AQL procedures through DQIP plans and audits.</li><li>Manage customer complaints (RMAs), ensuring timely investigations, root cause analysis, and resolution.</li><li>Engage in ADM QPL Committee to uphold compliance with military specifications (Mil-Spec) for government agencies such as DLA and Nav-Air.</li><li>Build team capabilities by developing robust succession plans and talent pipelines.</li><li>Report directly to the our client Hauppauge Plant Manager with a dotted-line report to the Regional Senior Quality Manager.</li></ul> Requirements: Qualifications &amp; Experience <ul><li>Education: Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical/quality discipline.</li><li>A graduate degree is a plus.</li><li>Experience:</li><li>Minimum 8 years of quality management experience in a discrete manufacturing environment.</li><li>Experience in Aerospace products markets is a plus.</li><li>Minimum 5 years of global leadership experience is preferred.</li></ul> Skills &amp; Competencies: <ul><li>Strong understanding of our client ADM business unit and Relay &amp; Contactors Plant Groups.</li><li>Ability to operationalize strategies for the Global Quality organization.</li><li>Strong leadership abilities in building effective teams and aligning them with company mission and standards.</li><li>Exceptional problem-solving, analytical, and technical writing skills.</li><li>Excellent communication, planning, and time management skills.</li><li>Ability to work at all levels of the organization with influence and strategic insight</li></ul>

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Site Investigation Lead, Quality Assurance

Mgr II Qlty & Reliability Engineering

Quality Manager

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Site Investigation Lead, Quality Assurance

Mgr II Qlty & Reliability Engineering

Quality Manager

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