Site Investigation Lead, Quality Assurance

Digital Marketing Specialist

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:&nbsp; <ul><li>Our client is seeking a dynamic and results-driven Digital Marketing Specialist to join our team on a freelance, project-based basis.</li><li>The ideal candidate will have hands-on experience in digital marketing, influencer marketing, and new media channels like podcasts, with a strong background in performance marketing.</li><li>This role offers an exciting opportunity to work with a growing company in the following industries: OTC Healthcare/Consumer Goods/Health and Wellness/E-commerce.</li></ul> Responsibilities: <ul><li>Partner with brand marketers to understand brand strategy, tactical plans, campaign requirements, data needs, and operational support associated with their digital marketing efforts</li><li>Plan and carry out marketing and promotional activities for the brand.</li><li>Ensure timely and compliant delivery of operational responsibilities in accordance with project milestones.</li><li>Serve as a subject matter expert for digital marketing best practices, internal processes, and systems related to digital marketing.</li><li>Help brand marketers ensure adequate data capturing and reporting are in place for all digital marketing initiatives.</li><li>Facilitate continued educational/training opportunities for internal marketing stakeholders and external agency teams</li><li>Gather future business requirements and represent the voice of the brand as additional digital marketing capabilities/platforms are established.</li><li>Cultivate strong partnerships with external agency teams, suppliers, and vendors in support of Brand and/or Digital Operations efforts.</li><li>Lead and execute media plans; Identify and optimize digital channel mix to help grow the brands.</li><li>Oversee all digital paid advertisements and third-party digital vendor management.</li><li>Analyze data by mapping current digital tactics to identify gaps, opportunities, and insights to optimize spend, performance &amp; ROI</li><li>Proficiency in core marketing capabilities such as digital creative development, segmentation, investment optimization, etc.</li><li>Experience in managing multiple external agency partners and internal marketing partners to meet deadlines in alignment with SOWs.</li><li>Work with overseas counterparts to ensure alignment of brand objectives.</li><li>Plan, conceptualize, and develop new product launches.</li><li>Manage media communication, advertising, and campaign/promotion on both offline and online (social media, Facebook, Instagram)</li><li>Manage brand presence in social networking sites including Facebook, Twitter, and other relevant blogs, sites, e-commerce, and forums</li><li>Monitor social media for conversations and trends related to company brand and feedback insights to the Regional to align overall business strategy</li><li>Measure the impact of social media programs; analyze, review and report on the effectiveness of our company’s social&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree (or) masters degree in marketing or related fields.</li><li>6+ years of relevant experience, preferable within the bio/pharma industry with at least 5 years of digital marketing experience</li><li>Exceptionally strong analytical skills, Communication Skills with the ability to evaluate KPIs, present learnings based on data and optimize</li><li>In-depth knowledge of digital marketing within the pharmaceutical or healthcare industry.</li><li>Freelance, Project-Based Work: Must be willing to work on a freelance, project basis, with flexibility on timelines and deliverables.</li><li>Operational Experience: Must have direct operational experience in digital marketing, influencer marketing, and new media, including podcasts.</li><li>Performance Marketing Expertise: Proven experience in performance marketing, with a focus on driving measurable results like conversions and ROI.</li><li>Proficiency in managing paid campaigns across multiple platforms (Google Ads, Meta, TikTok).</li><li>Experience in managing Influencer campaigns on Social Media platforms like Tik Tok, YouTube shorts and Meta.</li><li>Industry Experience: Experience in OTC healthcare, consumer goods, or consumer services is required.</li><li>Strong experience working closely with advertising agencies.</li><li>Self-Motivated &amp; Independent: Ability to manage projects independently and deliver results with minimal supervision.</li><li>Strong Communication Skills: Excellent written and verbal communication skills, with the ability to engage and collaborate with both internal teams and external partners.</li></ul> Why Join Us: <ul><li>Growth Opportunity: Be a part of a rapidly expanding company with a strong entrepreneurial culture.</li><li>Flexibility: Enjoy a remote working environment.</li><li>Impact: Play a crucial role in expanding the profile and reach of “Our client” and its brands in the US market. </li><li>If you are a motivated, strategic thinker with a passion for consumer marketing and sales, we invite you to apply and join our dynamic team at our client.</li></ul>

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Site Investigation Lead, Quality Assurance

Digital Marketing Specialist

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Site Investigation Lead, Quality Assurance

Digital Marketing Specialist

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.