• Quality Assurance Specialist II
• Marketing Coordinator
• Director of Government Affairs
• Boiron Consumer Experience Specialist

Quality Assurance Specialist II

Summary of Position:
The QA Specialist II must oversee and maintain compliance/regulatory activities as well as day-to-day Quality functions at the Newtown Square, PA or Simi Valley, CA facility. The candidate must be versatile, independent, an effective communicator and must have strong leadership skills. This individual will utilize QA experience to provide Quality Assurance leadership within branch operations.

Essential duties and responsibilities:

• QA Documentation development, management and approval;
• Development of assembly project batch records, finished product review and release;
• Development and review of equipment qualification and calibration documents;
• Develop and review facility qualification and maintenance documents;
• Develop and review equipment qualification and maintenance documents;
• Procedure development, update, distribution and implementation;
• Training of personnel in procedures and development of training programs;
• Initiation of investigations, root cause analysis, recommend and implement CAPA;
• Record, review, report, investigate, and file product problem complaints;
• Review, report, investigate, and file adverse event reports as requested;
• Conduct internal audits, identify non-conformances, recommend and implement CAPA;
• Conduct external audits, report findings;
• Validation and Stability study protocol development, coordination, review, and approval of documentation;
• Actively participate in regulatory inspections, acting as escort when requested, document meeting and inspection minutes, prepare reports and action lists from inspections, propose and implement recommendations for CAPA;
• Review of lab manufacturing batch documentation and finished product release;
• Review of microbiological testing documentation;
• Quality Control inspection of finished products;
• Review the receiving documentation for raw materials and components used in finished product manufacturing;
• Inspect and process product returns;
• Inspection of product in support of investigations;
• QA Documentation retention, filing and maintenance;
• Review of environmental monitoring data;
• Trend analysis of data as requested;
• Project management;
• Maintain open communication with branch teams to resolve challenges;
• All other duties as assigned.

Requirements:

• Education: Bachelor's degree in Life Science or related field.
• Minimum of 4 yrs. experience in QA/QC and /or Regulatory Affairs
• 2-3 years experience with FDA regulations and pharmaceutical cGMPs.
• Understanding of cGMP and pharmaceutical regulatory guidelines required.
• Knowledge of Microsoft Office software with ability to use Word and Excel spreadsheets with graphing.
• Demonstrate meticulous attention to detail in following procedures, preparing written documentation, and completing QA/QC activities;
• Work independently in a leadership role and enforce compliance goals and requirements;
• Ability to work in a high paced, multi-tasked environment.
• Have a strong affinity for team work.
• Self-starter that is hard working with demonstrated leadership, interpersonal and communication skill.
• Strong organizational skills.
• Ability to travel 10% domestic primarily; this may includes overnight and/or weekend travel

Marketing Coordinator

Summary of Position:
The Coordinator works with the daily activities in the Marketing Department and also assists with supporting activities of Marketing Director.

Essential duties and responsibilities:

• Assist with daily operation of the Marketing department ensuring smooth and efficient workflow
• Procures cost quotes and compares results between different vendors (US and French) for projects including displays, catalogs and packaging
• Coordinates regional advertising between the sales team, copywriter and graphics team.  Ensures Boiron message is consistent and accurate.
• Develops marketing materials and graphics for trade shows with the graphics team
• Develops and maintains competitor information database.  Research industry trends
• Maintain and update packaging database
• Assist in creation of presentations
• Organizes the preparation of proposals and presentations using marketing resource materials such as brochures, data, slides, photographs, and reports.
• Develop and nurture relationships with print and broadcast media within the framework of an overall media strategy.
• Maintains compliance with the vendor contract monitoring procedures.
• Tracks and measures the effectiveness of marketing materials.
• Coordinates trade shows
• Reviews and produces marketing materials
• Other duties as assigned

Requirements:

• Education: Bachelor’s Degree in Marketing, Advertising or Public Relations
• Enthusiastic team player with a positive attitude and winning track record
• 1-2 years of experience in Marketing
• Bi-lingual English/French Preferred
• Self-starter capable of delivering on goals with minimal supervision
• Excellent presentation/communication/influencing/negotiating skills, both written and verbal, required.
• Ability to travel domestic (primarily) and international (occasionally) locations (up to 30% travel required, equivalent to 5-6 trips annually), which may include overnight and/or weekend travel
• Work under deadline pressure and meet the deadlines.
• Proficient with operating a personal computer and use of MS Excel/Word/Outlook/PowerPoint and other required programs.
• Ability to interpret and disseminate information.
• Ability to be a creative thinker as well as an active listener.
• Must be able demonstrates personal integrity & honesty, as well as take responsibility

Director of Government Affairs

This position will be based out of Washington DC reporting to the President and CEO.

Summary of position:

The Director of Government Affairs directs strategic, policy and analytical activities associated with US Federal and State legislative matters pertinent to Boiron’s business interests.

Essential duties and responsibilities:

• Monitors and analyzes pending and enacted federal and state legislation, political activities, policies, guidance, and regulations relating to issues of interest to Boiron’s business.
• Consults with other managers and business leaders to ensure a thorough understanding of company operations, goals, and objectives. Seeks opportunity to introduce legislation and changes to public policy that will have a positive impact on company operations
• Identifies and communicates legislative issues and trends that impact the company including preparing memoranda and briefing materials
• May testify before legislative committees on behalf of the company or in support of industry groups.
• Identifies and communicates legislative issues to external parties similarly situated in order to build coalitions;
• Creates policy and develops strategy to support product and portfolio objectives as well as overall corporate/business objectives.
• Ensures Boiron is represented positively to current political, economic and industry influencers.
• Builds and maintains strong professional relationships with key influential legislators and officials who have significant input into the future direction of issues affecting Boiron.
• Develops and maintains relationships with appropriate Legislative  staff
• Actively participates in trade, industry and policy associations to shape positions and actions in furtherance of the company's goals and strategies.
• Engages  in political activity as approved by management including communicating with contract lobbyists elected officials and their staff members, interest groups and federal agencies to convey the company positions on issues
• Plan, monitor and direct strategic, tactical and managerial plans  for the Government Affairs department.
• Development and management of budget supporting Government Affairs annual operations.
• Coordinating activity to ensure that issues are communicated quickly and accurately to appropriate internal personnel and external lobbyists/legislators/interested parties.
• Develops as necessary, written analyses, advocacy and background materials in support of Boiron objectives.
• Development of Boiron policy position statements, papers, briefings, on Government related issues  as required.
• Develops grassroots plans for outreach externally and internally including drafting messaging, monitoring results and modifying plans as needed
• Perform other duties as assigned.

Requirements:

• BS/BA with government/political science, pre-law or related field
• Minimum 5 years experience in Federal government as legislative/executive staff required.
• Project management, public policy experience with government programs is highly desirable
• Lobbying experience desirable.
• Managerial experience desirable.
• Willingness to travel – up to 30%
• Excellent interpersonal, analytical, and communication skills, both oral and written.
• Ability to lead at all levels of the organization.
• Strong organizational, planning, conceptual and strategic thinking skills.
  
  

Boiron Consumer Experience Specialist

Summary of position: This position will respond to inquiries from the public including product-related questions and complaints, adverse reactions, general homeopathy, etc. through mail, e-mail, live telephone contact, and Web-based social platforms. This individual will also support Public Relations in social media, corporate Web presence-building and consumer outreach initiatives as well as assist Quality Assurance in managing complaints, related investigations, and documentation.

Essential duties and responsibilities:

• Answer consumer phone inquiries regarding product information and drug facts, product complaints and adverse events, and maintain related documentation.
• Respond to all mail and e-mail inquiries in a professional and timely manner.
• Manage the telephone system and outgoing messages.
• Respond to voicemails received after business hours in a timely manner.
• Manage contacts and information in the consumer inquiry database.
• Compile consumer inquiries data and issue reports on monthly basis or as needed.
• Manage product complaint documentation and coordinate sample collection for investigation.
• Conduct initial intake for adverse event reports and forward to appropriate Quality Assurance representative.
• Update, manage and maintain informational resources in paper and electronic formats.
• Assist record retention activities associated with all GMP documentation maintained by Quality Assurance.
• Maintain open communication with Operations to resolve challenges.
• Work independently with minimal supervision.
• Manage time effectively and utilize strong analytical/problem solving skills.
• Provide support and staffing at consumer events when required.
• All other duties as assigned.

Requirements:

• Bachelor's degree in Communications or related field.
• 2-4 years of customer service or call center experience preferred.
• Proficiency in Microsoft Office including Outlook, Word and Excel.
• Proficiency in social media applications including Facebook, Twitter and Youtube.
• Strong written and verbal communication skills; must be a strong active listener with a strong thought process.
• Strong organizational skills with attention to detail.
• Ability to work in a high-paced, multi-tasked environment.
• Ability to balance multiple responsibilities; adapt to changing corporate priorities; and meet deadlines.
• Ability to recognize and interpret trend data from consumer inquiries.
• Ability to work independently, manage own time and take initiative; or take direction to support a team or hired consultants.
• Ability to provide effective and timely resolutions for a wide range and high volume of customer inquiries.
• Self-starter with demonstrated leadership, interpersonal and communication skills.
• Build positive rapport with different types of consumers over the telephone or through Web-based social platforms.
• Demonstrated ability to diplomatically resolve consumer complaints and diffuse tension to ensure goodwill and customer retention.
• Ability to represent brand image of friendliness, empathy, and holistic lifestyle to general public.
• Ability to travel domestic (up to 10% travel required), which may include overnight and/or weekend travel